Status:
COMPLETED
Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Alcoholic Hepatitis
Alcoholic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 h...
Detailed Description
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 multice...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT01214226
Start Date
December 1 2007
End Date
January 1 2011
Last Update
June 1 2011
Active Locations (28)
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1
University hospital
Brussels, Belgium, 1070
2
University hospital
Angers, France, 49933
3
Centre hospitalier
Béthune, France, 62408
4
Hôpital Jean Verdier (AH-HP)
Bondy, France, 93143