Acute Alcoholic Hepatitis MedDRA version: 8.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders
Conditions
Interventions
Trade Name: Sulfasalazine
Product Name: Sulfasalazine
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFASALAZINE
CAS Number: 599791
Sponsors
Southampton University Hospitals Trust (R&D)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
United Kingdom
Outcome results
None listed