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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002837-19-GB

Enrollment

Registered

2007-02-26

Start date

2007-04-16

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Remestyp Pharmaceutical Form: Injection* INN or Proposed INN: Terlipressin CAS Number: 014636125 Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: We hypothesise that Terlipressin will be better than standard treatment in reducing the Maddrey’s score in severe acute alcoholic hepatitis. ;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.	—

Measure

Time frame

Main Objective: We hypothesise that Terlipressin will be better than standard treatment in reducing the Maddrey’s score in severe acute alcoholic hepatitis. ;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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026