STOPAH: Steroids or pentoxifyline for alcoholic hepatitis

Phase 3

Completed

• Conditions: Digestive System; Alcoholic hepatitis; Alcoholic liver disease

• Registration Number: ISRCTN88782125
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23958271 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25901427 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26691209 2020 results in https://pubmed.ncbi.nlm.nih.gov/33326633/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-26
• Study Completion: 2013-11-30
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1068

Inclusion Criteria

1. Clinical alcoholic hepatitis:
1.1. Serum bilirubin greater than 80 µmol/L
1.2. History of excess alcohol (greater than 80 g/day male, greater than 60 g/day female)
2. Less than 4 weeks from admission to hospital
3. Discriminant Function (DF) greater than or equal to 32
4. Informed consent
5. Minimum 18 years old, no upper limit, either sex

Exclusion Criteria

1. Abstinence of more than 6 weeks prior to randomisation
2. Duration of jaundice greater than 3 months
3. Other causes of liver disease
4. Evidence of current malignancy (except non-melanotic skin cancer)
5. Previous entry into the study, or use of either prednisolone or PTX within 6 months
6. Aspartate aminotransferase (AST) greater than 500 or alanine aminotransferase (ALT) greater than 300
7. Patients with a serum creatinine greater than 500 µmol/L or requiring renal support
8. Patients dependent upon inotropic support
9. Active gastro-intestinal haemorrhage and untreated sepsis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at 28 days

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mortality at 3 and 12 months<br> 2. Outcome relative to Glasgow Alcoholic Hepatitis Score<br> 3. Assessment of biochemical response to treatment<br> 4. Duration of hospitalisation<br> 5. The development of new or recurrent renal failure<br> 6. Development of gastro-intestinal haemorrhage and sepsis<br> 7. Incremental NHS costs and quality of life at 3 and 12 months<br>