A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
|ClinicalTrials.gov Identifier: NCT01143246|
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|HRS||Drug: Terlipressin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 3, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (REVERSE Trial)|
|Study Start Date :||September 2010|
|Primary Completion Date :||February 2013|
|Study Completion Date :||May 2013|
intravenous terlipressin (1 mg) every 6 hours with concomitant albumin
Blinded terlipressin reconstituted with 5 mL of sterile 0.9% sodium chloride solution for injection will be administered intravenously as a slow bolus injection over 2 minutes at a dose of 1 mg (1 vial) every 6 hours (4 mg/day).
Other Name: Lucassin®
Placebo Comparator: Placebo
Lyophilized mannitol reconstituted with 5 mL of sterile 0.9% sodium chloride solution administered intravenously as a slow bolus injection over 2 minutes at a dose of 1 mg (1 vial) every 6 hours (4 mg/day).
Other Name: Saline
- Confirmed Hepatorenal syndrome reversal [ Time Frame: Baseline and 14 days ]Confirmed HRS Reversal: The percentage of subjects with two serum creatinine (SCr) values of ≤ 1.5 mg/dL at least 48 hours apart, on treatment, and without intervening RRT or liver transplant.
- Hepatorenal syndrome reversal [ Time Frame: 14 days ]Incidence of HRS Reversal is defined as at least one SCr value of ≤ 1.5 mg/dL on treatment (up to 24 hours after the last dose of study medication).
- Transplant-free survival [ Time Frame: Up to 90 days ]Transplant-Free Survival up to 90 days, defined as the time (in days) that each subject survives without liver transplantation from the day of randomization.
- Overall Survival [ Time Frame: Up to 90 days ]Overall Survival up to 90 days, defined as the time (in days) that each subject survives from the day of randomization.
- Serious Adverse Events [ Time Frame: Up to 30 days post treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143246
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|Study Director:||Khurram Jamil, MD||Mallinckrodt|