Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Ministry of Health, France
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Pentoxifylline; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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