CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 82 enrolled
Drug / intervention
Terlipressin +1 moredrug
Likely dose
Terlipressin 8 gfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00986817
NCT00986817Phase 3Completed

Efficacy of Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin. A Multi-center Randomized Controlled Study

Assistance Publique - Hôpitaux de Paris·interventional·Posted Sep 30, 2009·Updated Jun 15, 2015

In Brief

A Phase 3 clinical trial evaluating Terlipressin and Placebo for Cirrhosis. Completed, enrolled 82 participants across 1 site.

Detailed Summary

Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.8 years ago

Interventions

Terlipressindrug

Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.

Placebodrug

albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.