A DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF TERLIPRESSIN IN THE MANAGEMENT OF SEVERE ALCOHOLIC HEPATITIS – A PRELIMINARY STUDY - Terlipressin and alcoholic hepatitis

Phase 1

• Conditions: Severe alcoholic hepatitis as judged by a Maddrey score >32; MedDRA version: 8.1 Level: LLT Classification code 10001624 Term: Alcoholic hepatitis

• Registration Number: EUCTR2006-002837-19-GB
• Lead Sponsor: DERBY HOSPITALS NHS FOUNDATION TRUST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Study Completion: 2012-01-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Men and women aged between 18 and 75 years
2. A history of current or within the last 30 days alcohol abuse (>50g / day women, >80g/day men)
3. A laboratory profile of hyperbilirubinaemia (bilirubin >80µmol/l), with an AST:ALT>1.5 and AST <300.
4. A Maddrey’s discriminatory function score of > 32 with no upper limit.
5. Patients must able to adhere to the study visit schedule and other protocol requirements.
6.Written informed consent will be obtained.

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

1. Evidence of acute GI haemorrhage in the 24 hours prior to receiving study drug.
2. Any terlipressin use within the last 28 days.
3. Severe cardiovascular disease including angina: assessed by clinical history or ECG evidence of ischaemic heart disease in the absence of positive history.
4. Severe pulmonary disease.
5. Concomitant proven bacterial infection.
6. The use of any other therapeutic agent targeted at using TNF-a levels or any other investigational drug within the three months of enrolment.
7. Evidence of any other concomitant liver disease.
8. Established hepato-renal syndrome.
9. Positive pregnancy test.
10. HIV positive (known).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: We hypothesise that Terlipressin will be better than standard treatment in reducing the Maddrey’s score in severe acute alcoholic hepatitis.<br><br> ;Secondary Objective: Our secondary objectives are to assess the effects of terlipressin on short-term survival (as assessed by mortality at Days 30 and 60), duration of hospital stay, progression to hepatorenal syndrome and on the course of other laboratory parameters including serum TNF levels.;Primary end point(s): The primary study endpoint is the Maddrey score in each treatment group at day 30.