STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis - STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis
- Conditions
- Severe alcoholic hepatitis
- Registration Number
- EUCTR2009-013897-42-GB
- Lead Sponsor
- Southampton University Hospitals NHS Trust R&D department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
Aged 18 years or older Clinical Alcoholic Hepatitis: • Serum bilirubin > 80µmol/L • History of excess alcohol (> 80g/day male, > 60g/day female) to within 2 months of randomisation Less than 4 weeks since admission to hospital. Discriminant Function* greater than or equal to 32. Informed consent * DF = 4.6 x (Prothrombin time (PTPATIENT – PTCONTROL) + Serum Bilirubin (µmol/l) / 17.1, (PTCONTROL is defined as the mean value at each centre, this mean value may be updated on a weekly or monthly basis)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Abstinence of more than 2 months prior to randomisation Duration of clinically apparent jaundice > 3 months Other causes of liver disease including: o Evidence of chronic viral hepatitis (Hepatitis B or C), o Biliary obstruction, o Hepatocellular carcinoma Evidence of current malignancy (except non-melanotic skin cancer) Previous entry into the study, or use of either prednisolone or prednisolone within 6 weeks of admission. AST >500 U/L or ALT >300 U/L. (not compatible with alcoholic hepatitis) Patients with a serum creatinine greater than 500 µmol/L or requiring renal support. Patients dependent upon inotropic support (adrenaline or noradrenaline). Glypressin is allowed. Active gastro-intestinal haemorrhage Untreated sepsis Patients with known hypersensitivity to pentoxifylline, other methyl xanthines or any of the excipients Patients with cerebral haemmorrhage, extensive retinal haemorrhage, acute myocardial infarction or severe cardiac arrhythmias Pregnant or lactating women Patients with evidence of sepsis, gastrointestinal bleeding or renal failure may be treated for these conditions for up to 7 days and then re-screened. Once the condition has been stabilised these patients will be randomised using stratified randomisation procedures. Recent gastrointestinal bleeding: Gastrointestinal bleeding will be treated and the patient stabilised for at least 48 hours prior to screening and randomisation. Sepsis: All patients will be screened for infection as part of routine care. Positive culture and initiation of antibiotics with clinical or radiological signs of infection; as well as clinical suspicion will be recorded as sepsis. Patients with evidence of sepsis will be treated for a minimum of 2 days with appropriate antibiotics. Once the local principal investigator considers that the sepsis is under control then the patient may be rescreened and randomised. Renal Impairment: Patients who are oligo-anuric, have a creatinine > 500 uM/L or who require renal support will be given appropriate resuscitation therapy for up to 1 week. These patients may then be rescreened and considered for randomisation once they meet eligibility criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether prednisolone or pentoxifylline improve the 28 day mortality (death rate) from severe alcoholic hepatitis.;Secondary Objective: To determine the death rate from alcoholic hepatitis at 1 year following admission to hospital in patients treated with pentoxifylline or prednisolone To evaluate the economic cost of treating severe alcoholic hepatitis;Primary end point(s): Mortality rate at 28 days following start of treatment
- Secondary Outcome Measures
Name Time Method