The Use of Sulfasalazine as an Anti-fibrotic in Acute Alcoholic Hepatitis - SZP in alcoholic hepatitis

Conditions: Acute Alcoholic Hepatitis
MedDRA version: 8.1Level: SOCClassification code 10019805Term: Hepatobiliary disorders

Registration Number: EUCTR2006-004419-24-GB

Lead Sponsor: Southampton University Hospitals Trust (R&D)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All patients will have a diagnosis of acute alcoholic hepatitis based on clinical findings, history of alcohol consumption of >80g/day for men and 60g/day for women and liver histology. Other causes of liver disease will be excluded by standard investigations. The diagnosis of alcoholic hepatitis will be confirmed by liver biopsy prior to trial entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Informed consent refused by patient.
Clearly moribund patients or patients with evidence of established irreversible triple organ failure in whom survival is extremely unlikely.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether Sulfasalazine (an inhibitor of NFkappaB activation and hepatic stellate cell activation in vitro and in vivo) is an effective human anti-fibrotic agent in the treatment of accelerated liver fibrosis associated with acute alcoholic hepatitis. ;Primary end point(s): Matched liver fibrosis scores pre- and post-treatment. Biopsies will be blinded and assessed by two independent expert liver histopathologists.;Secondary Objective: To evaluate whether Sulfasalazine treatment reduces the development of cirrhosis and in time the morbidity and mortality from alcoholic hepatitis. <br>The effects of treatment on specific molecular markers of liver fibrosis, namely collagen type I, alpha smooth muscle actin, tissue inhibitors of metalloproteinases and other mediators will also be analyzed.

Secondary Outcome Measures