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Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

NCT02770716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-11-29

Study results available
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Summary

This study is to treat adult patients with hepatorenal syndrome (HRS) Type 1.

Out of every three participants, two will receive terlipressin and one will receive placebo.

Assignments will be made randomly.

Conditions

  • Hepatorenal Syndrome

Interventions

DRUG

Terlipressin

Terlipressin solution for injection

OTHER

Placebo

Matching placebo solution for injection

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Clinical Team Lead · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-13
Primary Completion
2019-07-24
Completion
2019-07-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770716 on ClinicalTrials.gov