A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
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|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|
|Actual Primary Completion Date :||February 2013|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143246
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|Study Director:||Khurram Jamil, MD||Mallinckrodt|