Short-term Survival in Patients With Severe Alcoholic Hepatitis Treated With Steroid Versus Pentoxifylline
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ClinicalTrials.gov Identifier: NCT01455337 |
Recruitment Status
: Unknown
Verified October 2011 by Seung Ha Park, Inje University.
Recruitment status was: Enrolling by invitation
First Posted
: October 19, 2011
Last Update Posted
: October 19, 2011
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Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease. Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate. Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve cytokine release and the perpetuation of injury by immunologic process, corticosteroid has been extensively evaluated in the treatment of alcoholic hepatitis. Although there are discrepancies in literature as several randomized trials and meta-analyses have reached contradictory results, corticosteroid for a subset of patients with severe alcoholic hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been recommended. This latter point emphasizes the important of meticulous selection to avoid the side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly selected minority group in which the inhibitory effect of corticosteroid on liver inflammation is not outweighed by side effects such as weakened defense against infection, anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal bleeding, which may be deleterious in these critically ill patients.
Newer understanding of the role of the role of TNF-α expression and receptor activity in alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor, recently has been demonstrated in a randomized trial to improve survival in the therapy of severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to be related to a significant reduction in development of hepatorenal syndrome. These results are promising, and support the need to further evaluate the potential of this new therapeutic avenue.
There is a need for head to head comparison of corticosteroid and pentoxifylline in severe alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone, an active form of prednisone. The aim of the present study was thus to compare the effects of pentoxifylline and prednisolone on the short-term mortality.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholic Hepatitis | Drug: pentoxifylline Drug: Prednisolone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Principal Investigator |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: prednisolone |
Drug: Prednisolone
40mg qd
|
Experimental: pentoxifylline |
Drug: pentoxifylline
400mg tid
|
- survival rate [ Time Frame: at 1-month ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of Severe alcoholic hepatitis (discriminant function ≥ 32 points), Must be able to swallow tablets.
Exclusion Criteria:
- Gastrointestinal bleeding Bacterial infection HBsAg positivity Acute pancreatitis
Responsible Party: | Seung Ha Park, MD, Inje University |
ClinicalTrials.gov Identifier: | NCT01455337 History of Changes |
Other Study ID Numbers: |
1111 |
First Posted: | October 19, 2011 Key Record Dates |
Last Update Posted: | October 19, 2011 |
Last Verified: | October 2011 |
Keywords provided by Seung Ha Park, Inje University:
severe alcoholic hepatitis |
Additional relevant MeSH terms:
Hepatitis, Alcoholic Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |
Prednisolone acetate Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Pentoxifylline Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |