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A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

Study:

Phase 3, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (REVERSE Trial)

Rationale:

n/a

Purpose:

This study is designed to evaluate the efficacy and safety of intravenous Lucassin® (terlipressin) versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in subjects receiving standard of care albumin therapy.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Hepatorenal Syndrome Type 1 Drug: Terlipressin
Drug: Placebo
Phase 3

Verified by Ikaria Holdings Inc. July, 2013

Sponsored by: Ikaria Holdings Inc.
Information provided by: Ikaria Holdings Inc.
ClinicalTrials.gov identifier: NCT01143246

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Khurram Jamil, MD., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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