Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-01-31

Brief Summary

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The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.

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Detailed Description

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The aim of the present study is to determine whether or not the adjunction of Pentoxifylline to corticosteroids would improve 6-month survival of patients with severe alcoholic hepatitis. This multicenter, randomized, double-blinded, controlled, phase 3 trial was conducted in 24 centers located in France and Belgium. Alcoholic hepatitis was biopsy-proven. All eligible patients were randomly assigned in a 1:1 ratio to receive corticosteroids + Pentoxifylline or corticosteroids + Placebo. The primary outcome of the study was 6-month survival. Assuming a two-sided type I error of 0.05, a randomization ratio of 1:1 between the 2 groups, 6-month survival of 64% in the Placebo and Corticosteroids group and of 78 % in the Pentoxifylline and Corticosteroids group, we estimated that with 268 randomized patients (134 in each group), the study would have a power of 80% to detect this increase in 6-month survival in the Pentoxifylline and Corticosteroid group.

Conditions

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Alcoholic Hepatitis Alcoholic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pentoxifylline + Prednisolone

Pentoxifylline 400 mg prolonged-released tablets 3 time a day \[1200 mg/day\]

\+ Prednisolone 2 ORODISPERSIBLE TABLETS OF 20 MG 1 TIME PER DAY \[40 mg/day\]

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

prolonged-release tablets 3 time per day for 1 month

Placebo + Prednisolone

Placebo prolonged-release tabled 3 time a day

\+ Prednisolone 2 ORODISPERSIBLE TABLETS OF 20 MG 1 TIME PER DAY \[40 mg/day\]

Group Type PLACEBO_COMPARATOR

Pentoxifylline

Intervention Type DRUG

400 mg prolonged-released tablets 3 time per day for 1 month.

Interventions

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Pentoxifylline

400 mg prolonged-released tablets 3 time per day for 1 month.

Intervention Type DRUG

placebo

prolonged-release tablets 3 time per day for 1 month

Intervention Type DRUG

Other Intervention Names

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TORENTAL 400MG

Eligibility Criteria

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Inclusion Criteria

* Alcohol consumption more than 40 gram/day for women and 50 gram/day for men
* Maddrey discriminant function higher than 32
* Onset of jaundice within the 3 previous months
* Biopsy-proven alcoholic hepatitis

Exclusion Criteria

* Hypersensitivity to pentoxifylline
* Any severe disease that may potential affect survival such as cardiac failure, ischemic cardiopathy, respiratory failure
* Any neoplasm that occurred within the 2 previous years
* Hepatocellular carcinoma or any previous diagnosis of hepatocellular carcinoma
* Portal thrombosis
* Severe gastrointestinal bleeding
* Uncontrolled sepsis within the 7 previous days
* Hepatorenal syndrome type I
* Viral and fungal infection
* Acute pancreatitis
* Any tuberculosis that occurred within the 5 previous years
* Psychiatric disorders that contraindicate the use of corticosteroids
* Infection related to virus of the hepatites B or C
* HIV infection (Human immunodeficiency virus)
* Any treatment with corticosteroids, immunosuppressive agents, budesonide, thalidomide or pentoxifylline that was given within the previous year
* Pregnancy or breast feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No