Prednisolone or pentoxifylline for alcoholic hepatitis - This Changed My Practice.Prednisolone in Severe Alcoholic Hepatitis - Wiki Journal Club
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In a sea of studies yielding conflicting results, the present study was one of the first to suggest a survival benefit of glucocorticoids among patients with severe alcoholic hepatitis.
This trial randomized 61 patients with severe, biopsy-proven alcoholic hepatitis to prednisolone or placebo. This survival benefit was also seen at 6 months. In contrast to other trials, the prednisolone group experienced fewer GI bleeds and infections, which one would have expected to be more common in the glucocorticoid group.
A Cochrane Review [1] suggests that there is insufficient data to support or advise against the routine use of steroids in alcoholic hepatitis. The subsequent Pentoxifylline in Severe Alcoholic Hepatitis suggested that pentoxifylline may also improve survival in severe alcoholic hepatitis.
There was no mortality benefit with pentoxifylline, but prednisolone was associated with a non-significant trend towards mortality reduction at 28 days OR 0. From Wiki Journal Club. Ramond MJ, et al. The New England Journal of Medicine. Categories : Usable articles Gastroenterology. Navigation menu Personal tools Create account Log in. Namespaces Page Discussion. Views Read View source View history. Main page Usable articles Recent changes Random page About.
❿- Prednisone alcoholic hepatitis
Prednisone alcoholic hepatitis
Eligibility Criteria. Clinically active C. Positive test is exclusionary only during screening period. Contacts and Locations.
Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Alcoholic Hepatitis. Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Active Comparator: Prednisone Standard of care plus prednisone 40 mg orally once daily on Days and matching placebos for Anakinra 1 syringe s.
A further component surrounding the need for and utility of liver biopsy in the diagnosis of AH revolves around the distinction between acute-on-chronic liver failure ACLF and AH. ACLF is a relatively new concept in hepatology, with varying definitions proposed. In most definitions, ACLF describes a subset of cirrhotic patients with rapidly progressive decompensation, multiorgan failure, and high short-term mortality. Because nearly all patients with severe AH are already cirrhotic and often present with multiorgan dysfunction, it is possible that the majority of ACLF is simply severe AH.
Although liver biopsy is not essential to diagnose AH, it is useful in cases of diagnostic uncertainty, as differentiating severe AH from nonalcohol-related liver diseases based upon clinical parameters alone can lead to different management plans.
There is no shortage of protocols designed to predict the outcome of a patient with severe AH, and it is important to learn how to use the prediction models currently available, as they share many similar elements Table 2.
The discriminant function DF was first described by William Maddrey in The DF is highly sensitive to identifying patients with AH at risk of early mortality and has decades of study as the key inclusion criterion for -numerous prospective clinical trials of AH treatment.
However, its specificity is suboptimal, as many patients with a DF of 32 or higher survive even without AH-specific treatment. The DF is also limited as a static, dichotomous variable calculated at the time of admission.
In the United States, the control PT is not commonly reported and usually requires a managing provider to contact a laboratory to confirm the correct value usually the mean of the reference range. Because control PT values can differ by laboratory and change over time based upon reagents used and methodology, attention should be paid to this issue, especially in retrospective clinical research.
The Lille model was born out of a clinical observation that an early change in bilirubin levels after initiation of glucocorticoids was associated with improved prognosis. The Lille model differs from other prediction models in that it was designed to influence clinical decision-making by augmenting the DF to assess the likelihood of response to glucocorticoids in a well-characterized, biopsy-proven cohort of AH patients with a DF of at least A Lille score of 0.
MELD accurately predicts outcome in AH and has the benefit of capturing renal function, which has been -independently associated with outcomes in severe AH. MELD has the added benefit of being a commonly used dynamic and continuous model that can be measured at different time points to assess prognosis.
However, there is no consensus as to the MELD threshold value defining poor prognosis at which glucocorticoids or other -therapies would be useful. The score considers age and white blood cell count as shared variables with the other models. Given the high risk of short-term mortality, an AH model would preferably have a high sensitivity to identifying all AH patients at risk.
Additionally, a GAHS of 9 or higher identified patients who benefited from glucocorticoids, compared with a DF of at least 32 and a GAHS less than 9, where no appreciable difference between untreated or glucocorticoid-treated patients was found. The age, serum bilirubin, INR, and serum creatinine ABIC model is a newer prediction model, derived and validated in a Spanish biopsy-proven AH cohort, that stratifies patients into low, intermediate, and high risk of mortality at 90 days and 1 year.
Of note, mild or absent neutrophil infiltration confers points toward a higher risk of mortality compared with severe neutrophil infiltration. This may seem contrary to a higher serum white blood cell count conferring higher risk in the GAHS and Lille model, with a feature of systemic inflammatory response syndrome SIRS likely playing an unascertained role.
Several studies have performed retrospective application of the 6 clinical prediction models discussed above. Using heterogeneous study cohorts, these case series demonstrate that the clinical prediction models perform similarly well at predicting outcomes in AH, with the area under the curve ranging from 0.
A recent study evaluated various combinations of the dynamic Lille model with static models for outcome prediction in AH. Treatment of severe AH begins with cessation of alcohol consumption. It is unknown whether a safe lower threshold for alcohol consumption exists for patients with AH.
Therefore, all patients with AH are advised to establish and maintain abstinence. The roles of treatments in controlling craving for alcohol or of psychotherapies in supporting abstinence have not been established for AH.
Based upon other forms of alcoholic liver disease, for which there are also a paucity of good data, patient-tailored psychotherapies are recommended once the patient has achieved sufficient health to participate. Many patients with severe AH and underlying cirrhosis have protein-calorie malnutrition, making nutritional replenishment an obvious place to begin treatment.
Enteral nutrition via a nasogastric tube is sometimes considered, although good data to support it are few. Enteral nutrition may also play a role in reducing bacterial translocation in the gut by maintaining gut barrier function that may reduce the incidence of infections. European investigators reported the results of a multi-center, randomized, controlled trial comparing 2 arms: the intensive group, which received intensive enteral nutrition plus methylprednisolone, and the control group, which received conventional nutrition plus meth-yl-prednisolone.
The authors reported a significant improvement in 6-month survival rates on a per-protocol analysis On intention-to-treat analysis, however, no statistical difference was found in 6-month survival rates. Glucocorticoids are the most extensively studied inter-vention in AH treatment, with more than 16 clinical trials that date back almost 40 years.
There is currently a general agreement that glucocorticoids should be part of first-line therapy in patients with AH and a DF of at least 32 without contraindications. Aside from the fact that most clinical trials use prednisolone, there is also a pharmacologic concern over the diminished hepatic metabolism of prednisone the prodrug to prednisolone in a dysfunctional liver. The putative mechanisms are impairment of the hepatic enzyme beta-hydroxysteroid dehydrogenase, which renders the oxosteroids cortisone and prednisone biologically active, and impairment of ring A reduction of prednisolone, which leads to persistence of this biologically active metabolite.
Depending on availability, oral prednisolone comes in liquid form and is often formulated with alcohol, making tapering difficult and prompting questions by pharmacists and patients. Methylprednisolone tablets are another widely available option but require dose conversion, as the drug has a relative potency of compared with prednisolone or prednisone. Practically, prednisolone tablets are preferred; however, if they are not available, prednisone may be used to treat severe AH.
Providers are often reticent to start patients with severe AH on glucocorticoids due to side effects and infection risk. There is a significant overlap between the clinical presentations of AH and sepsis. Given these risks, a practical approach should be used in considering patients for glucocorticoids in severe AH. Upon admission, clinicians should obtain blood, urine, ascitic fluid cultures if present , and chest -radiograph and abdominal imaging eg, ultrasound with Doppler , and should avoid empiric antibiotics and intravenous contrast.
Glucocorticoids should be started if a clinical diagnosis of severe AH is made and if cultures are negative at 24 to 48 hours with a low clinical suspicion of infection and a lack of other contraindications Table 3. Furthermore, when cultures reveal an infection, glucocorticoids may be started after 48 hours of treatment with appropriate antibiotics.
For example, 5 recent studies of glucocorticoids in severe AH had a median DF ranging from 54 to 71 with similar rates of mortality. Nonetheless, it is reasonable that the presence of a DF higher than 54 would cause the provider to thoroughly assess the patient for undiagnosed infection causing cholestasis of sepsis prior to initiation of glucocorticoids. The Lille score should be calculated after 7 days of corticosteroid use.
If the score is greater than 0. If any of the common complications of severe AH Table 3 develop during treatment, particularly infection and acute kidney injury, glucocorticoids should be stopped to avoid exacerbating the infection and because of the lack of data that glucocorticoids are salutary in severe AH with acute kidney injury.
In one study, glucocorticoids were not associated with a higher short-term risk of infections. The authors note that controlled infections may allow for resumption of glucocorticoids, as this strategy enables recovery of liver function, which is ultimately paramount in protecting against future infection and improving survival.
Pentoxifylline is a xanthine derivative that weakly mitigates production of tumor necrosis factor alpha in vitro.
Because tumor necrosis factor alpha has been proposed to play a major role in the pathogenesis of AH, -pentoxifylline gained support as a treatment for AH. A Cochrane meta-analysis reporting on 5 clinical trials of pentoxifylline in patients with AH and a DF greater than 32 concluded that pentoxifylline could not be supported or rejected for treating AH. Three head-to-head clinical trials comparing pentoxifylline to glucocorticoids in Asia provided conflicting results. The study enrolled subjects.
In brief, the STOPAH trial demonstrated that only prednisolone improved day survival rates and that neither prednisolone nor pentoxifylline alone or in combination improved longer-term survival at 90 days and 1 year. Pentoxifylline was no better than placebo in reducing mortality, but was associated with fewer infections than glucocorticoids. In order to achieve the necessary enrollment, recruitment was extended to community hospitals lacking the facilities to undertake transjugular liver biopsy.
Therefore, the diagnosis of AH was based on clinical grounds alone. The lack of liver biopsy confirmation of AH may have diluted the study population by including subjects without AH, thereby diminishing the study power. This indirectly supports the notion that the heterogeneity of severe AH made enrollment difficult despite its optimal study design and large size.
The trial has largely shown that pentoxifylline is a failed therapy for AH while also demonstrating that prednisolone is ineffective beyond 1 month to improve survival. Clinical trials of AH treatments typically exclude patients with active infection, acute kidney injury usually hep-atorenal syndrome , gastrointestinal bleeding, and acute pan-creatitis, all of which are frequent concomitant problems arising in this patient population.
In a recent retrospective French study comparing patients with AH to those with AH and gastrointestinal bleeding, the latter group had a lower rate of infections, but no difference was found in 6-month survival rates with acceptable performance of the Lille model. In mouse models of acute and chronic AH, N-acetylcysteine NAC has been shown to be ameliorative, presumably by reconstituting glutathione reserves to reduce oxidative stress.
Because 6-month mortality was the primary endpoint, the study was considered a negative trial for this combination therapy. Targeting the regenerative aspects of the liver in AH, granulocyte-colony stimulating factor G-CSF mobilizes hematopoietic stem cells, induces liver regeneration, and improves survival in experimental models. This potential therapy for severe AH is intriguing given its promotion of hepatic regeneration rather than abrogation of inflammation.
However, the origin of functional hepatic progenitor cells eg, liver, peripheral blood leading to regeneration is still in debate. Until very recently, patients with severe AH were not considered appropriate candidates for LT, mainly on account of a lack of 6-month sobriety prior to LT. Comprehensive psychosocial assessments by an addiction specialist were performed to identify those with lower risk of alcohol relapse.
The authors used 2 methods to construct historical controls. While this pilot trial demonstrated the medical and surgical feasibility of early LT for severe AH, adoption of this strategy has been cautious given the uncertainty of the psychosocial assessment process and the ethical ramifications of this essentially new indication for LT.
The complex psychosocial profiles of potential candidates were also examined in detail. Importantly, the recipient who relapsed failed to meet these 2 criteria. These results and analysis provide an early roadmap for other LT centers considering this indication as a rescue therapy for severe AH. Due to the paucity of treatment options for AH, a major initiative from the National Institute on Alcohol Abuse and Alcoholism has spearheaded large multi-institutional consortia with the task of identifying new therapeutic targets and performing early-phase clinical studies to develop and test new drugs for managing AH.
A review of these rational and targeted potential therapies has been published. An early example is from a clinical trial in which daily oral zinc mg , a known stabilizer of gut-barrier function, improved liver inflammation, fibrosis biomarkers, liver function, and clinical parameters albumin levels, Child-Pugh scores in alcoholic cirrhosis.
This review of AH identified 4 key controversies that impact the diagnosis, prognosis, management, and treatment of patients with severe AH. Liver biopsy can be useful in cases of diagnostic uncertainty with milder hepatic decompensation, but it is not required in order to diagnose AH.
Oral prednisolone can be used with intravenous NAC to improve short-term survival in patients with severe AH. Concurrent enteral nutrition is emphasized, along with patient-centered psychotherapy when medically appropriate, to improve long-term survival. Patients with severe AH who are nonresponders to medical therapy with good psychosocial profiles may be referred to transplant centers that are performing early LT for this indication.
Looking forward, the ongoing multi-institutional consortia yielding new insights and treatments will shape the management of AH for years to come. Alcoholic hepatitis. N Engl J Med. Liver related mortality in the US is underestimated. Excess weight risk factor for alcoholic liver disease. Chayanupatkul M, Liangpunsakul S. Alcoholic hepatitis: a comprehensive review of pathogenesis and treatment. World J Gastroenterol. Alcoholic hepatitis: current challenges and future directions.
Clin Gastroenterol Hepatol. N Engl J Med A randomized trial of prednisolone in patients with severe alcoholic hepatitis. Survival and prognostic factors in patients with severe alcoholic hepatitis treated with prednisolone. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data.
Pentoxifylline improves short-term survival in severe acute alcoholic hepatitis: a double-blind, placebo-controlled trial. Pentoxifylline for alcoholic hepatitis. Systematic review: pentoxifylline for the treatment of severe alcoholic hepatitis. Pentoxifylline vs. J Hepatol ; Pentoxifylline versus prednisolone for severe alcoholic hepatitis: a randomized controlled trial. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial.
JAMA Corticosteroid plus pentoxifylline is not better than corticosteroid alone for improving survival in severe alcoholic hepatitis COPE trial. Dig Dis Sci Treatment of Severe Alcoholic Hepatitis. This communication reflects the opinion of the author and does not necessarily mirror the perspective and policy of UBC CPD. Comments are moderated according to our guidelines.
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By Dr. Paul Mullins on October 26, Alcoholic hepatitis AHperhaps more accurately described as alcohol-related cholestatic liver failure 1is a clinical syndrome in those chronically consuming alcohol to excess presenting with jaundice and liver failure. Challenges for clinicians in managing these patients include making an accurate diagnosis, assessment of severity and the approach to treatment 2.
A diagnosis of predominant AH is made when certain clinical, biochemical, and imaging features are present in chronic excess alcohol consumption. Liver biopsy, by the trans-jugular route in significant coagulopathy, is more often used to assist in diagnosis in Europe whereas in North America, and the UK, its use is generally restricted to cases where an alternative diagnosis is considered.
Assessment of severity Several scoring systems have been used to identify severe AH, which has a higher mortality, for which specific drug treatment may improve survival. Scores are not used for diagnosis of AH, and have limitations 2 :. Odds ratios were as follows: Pentoxifylline 1. There were no significant differences in outcomes between the groups at 90 days, and at 1 year.
According to this power calculation, a sample size ofper group of single agent versus no single agent, would be required, thus the overall trial sample size would require 1, patients. The power calculation assumed no interaction between the treatments. In response the authors state that mortality rates are similar to trials published in recent years, and that differences in mortality between studies are most likely to reflect variations in patient factors and improvements in general management over the years.
These factors include greater number of well-nourished younger patients, improvements in supportive care, lower incidence of infection, acute kidney injury and hepatic encephalopathy. Other factors predicting mortality in this study, Prednisolone use, levels of INR, Bilirubin, Creatinine, Urea, white blood cell count, compared to previous trials were similar. Absence of liver biopsy in this trial may have resulted in inaccurate diagnosis leading to a reduced power of the study to detect a therapeutic effect.
The authors state, however, that use of liver biopsy, except when an alternative diagnosis is suspected, is controversial, and is not performed routinely in most units managing patients with AH.
Results from this pragmatic clinical trial provide evidence that Pentoxifylline does not improve mortality in severe AH. Use of Prednisolone does not improve mortality either, except in the short term in a small proportion of patients, and that the reduced mortality rate is not maintained at one year.
I do not use Pentoxifylline in the treatment of severe AH and restrict the use of corticosteroid therapy in this condition. My approach to corticosteroid therapy in severe AH is as follows:.
The importance of general management of associated conditions, and the need for new treatments to reduce short-term mortality in severe AH, is emphasised Reduction of long-term mortality remains dependent upon maintained abstinence. Prednisolone or pentoxifylline for alcoholic hepatitis. View Results. Read More No Comments.
Notify me of followup comments via e-mail. You can also subscribe without commenting. Prednisolone or pentoxifylline for alcoholic hepatitis By Dr. Paul Mullins on October 26, Dr.
Paul Mullins MBBS DM FRCP biography, no disclosures What I did before Alcoholic hepatitis AHperhaps more accurately described as alcohol-related cholestatic liver failure 1is a clinical syndrome in those chronically consuming alcohol to excess presenting with jaundice and liver failure.
Limitations of mDF include that the prothrombin time used in the score underestimates severity of disease 7. The MELD score has been shown to predict survival overall 8. GAHS may be superior in identifying those who will benefit from corticosteroid treatment Treatment General Supportive care and management of associated problems encountered in these patients includes the following: alcohol withdrawal; alcohol-related neurological complications; complications of cirrhosis: sepsis; hepatorenal syndrome; acute bleeding; acute kidney injury; hepatic encephalopathy.
Once the patient is clinically stable nutritional support, via oral or nasogastric route, is commenced. Specific A number of drugs have been considered as specific treatment for severe AH. Guidelines recommend Prednisolone 40 mg a day PO, or Pentoxifylline mg three times a day PO, for four weeks 5, 6, I ensure that there has been no active sepsis or acute bleeding for 48 hours before commencing specific drug treatment for severe AH.
The benefit of corticosteroids and Pentoxifylline in severe AH is controversial. There is a lack of definitive evidence for reduction in mortality with corticosteroids 14, 15, 16, 17, 18Pentoxifylline 19, 20, 21or in combination 22, 23, 24, What I do now I do not use Pentoxifylline in the treatment of severe AH and restrict the use of corticosteroid therapy in this condition.
Ensure general management has been established, the patient is clinically stable with absence of active sepsis or hemorrhage for 48 hours. Make a general assessment of patient fitness to withstand complications and side effects of corticosteroids eg. Current treatment options for alcohol-related liver disease. Curr Opin Gastroenterol Alcoholic Hepatitis: current challenges and future directions. Clin Gastroenterol Hepatol Early Mortality of alcoholic hepatitis: a review of data from placebo-controlled clinical trials.
World J Gastroenterol Management of alcoholic hepatitis. J Hepatol 56 suppl 1 : S Hepatol 51 1 : J Hepatol Corticosteroid therapy of alcoholic hepatitis. Gastroenterology MELD accurately predicts mortality in patients with alcoholic hepatitis. Hepatology Analysis of factors predictive of mortality and derivation of and validation of the Glasgow alcoholic hepatitis score. Gut A new scoring system for prognostic stratification of patients with alcoholic hepatitis. Am J Gastroenterol View Alcohol-use disorders: Diagnosis and clinical management of alcohol-related physical complications.
NICE Guideline The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Systematic review: glucocorticosteroids for alcoholic hepatitis — a Cochrane Hepato-Biliary Group systematic review with meta-analyses and trial sequential analyses of randomized clinical trials. Aliment Pharmacol Ther Short-term and long-term survival in patients with alcoholic hepatitis treated with oxandrolone and prednisolone. N Engl J Med A randomized trial of prednisolone in patients with severe alcoholic hepatitis.
Survival and prognostic factors in patients with severe alcoholic hepatitis treated with prednisolone. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Pentoxifylline improves short-term survival in severe acute alcoholic hepatitis: a double-blind, placebo-controlled trial. Pentoxifylline for alcoholic hepatitis.
Systematic review: pentoxifylline for the treatment of severe alcoholic hepatitis. Pentoxifylline vs. J Hepatol ; Pentoxifylline versus prednisolone for severe alcoholic hepatitis: a randomized controlled trial. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial.
JAMA Corticosteroid plus pentoxifylline is not better than corticosteroid alone for improving survival in severe alcoholic hepatitis COPE trial. Dig Dis Sci Treatment of Severe Alcoholic Hepatitis. This communication reflects the opinion of the author and does not necessarily mirror the perspective and policy of UBC CPD. Comments are moderated according to our guidelines. Visit ubccpd. Previous Next. Click here to print this article. Read Later. Adeera Levin Dr. Alexander Chapman Dr. Alice Chang Dr.
Alisa Lipson Dr. Alissa Wright Dr. Amanda Hill Dr. Amin Javer Dr. Amin Kanani Dr. Andrew Farquhar Dr. Andrew Howard Dr.
Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis (AH): individual data analysis of the last three. The treatment of choice for patients with severe alcoholic hepatitis (AH) is use of corticosteroids. Many randomized well designed studies have been. Steroids or Pentoxyfilline for Alcoholic Hepatitis (STOPAH) trial, prednisolone almost doubled between prednisolone and liver function, infection, and. Prednisone is not widely used for alcoholic hepatitis since it has to be metabolized to prednisolone by the liver but is probably acceptable in a dose of Alcoholic Hepatitis, Drug: Anakinra and Zinc Drug: Prednisone Drug: such as prednisolone, are considered standard of care in alcoholic liver disease. Acute-on-chronic liver failure: recent concepts. Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation. Since there have been 13 randomised studies and four meta-analyses investigating the role of corticosteroid therapy for alcoholic hepatitis [ 11 ]. Incretin Safety: What is the Evidence? Terence Yung Dr.Study record managers: refer to the Data Element Definitions if submitting registration or results information. This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis AH , a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases.
The primary objective of the study is to determine the clinical efficacy and safety of Anakinra plus zinc compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH.
Key secondary objectives broadly are as follows: a to evaluate the use of biomarkers to assess disease severity and treatment response; and b to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Drug: Prednisone Prednisone is indicated for numerous conditions including inflammatory disease. Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
Drug: Anakinra and Zinc Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : September 16, Study Description.
Drug Information available for: Prednisone Zinc, elemental Anakinra. FDA Resources. Arms and Interventions. Prednisone is indicated for numerous conditions including inflammatory disease. Standard of care plus Anakinra mg s. Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis.
Outcome Measures. Primary Outcome Measures : Survival at 90 days [ Time Frame: 90 days ] The primary analysis will be comparisons of day mortality of Prednisone and Anakinra plus zinc vs Prednisone. It gives each person a 'score' number based on how urgently he or she needs a liver transplant within the next three months. Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation.
New onset of ascites if not present on admission to study New onset of variceal hemorrhage New onset of hepatic encephalopathy HE. Life-threatening organ dysfunction caused by a dysregulated host response to infection An increase in SOFA score of 2 points of more Note: most participants with severe AH have 4 points based on bilirubin only.
Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT. Eligibility Criteria. Clinically active C. Positive test is exclusionary only during screening period. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Alcoholic Hepatitis. Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :.
Active Comparator: Prednisone Standard of care plus prednisone 40 mg orally once daily on Days and matching placebos for Anakinra 1 syringe s. Drug: Placebos Matching placebo. Indianapolis, Indiana, United States, August 28, Key Record Dates.
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