Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1 - Tabular View

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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

This study has been completed.
Information provided by Orphan Therapeutics

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Official Title ^†

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1

Brief Summary

The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Survival with reversal of HRS

Secondary Outcome Measure ^†

Renal function and survival

Condition ^†

Hepatorenal Syndrome

Intervention ^†

Drug: terlipressin

MEDLINE PMIDs

12016430, 12164964, 11051385, 9824265, 11981339, 11910344, 11322061, 12542598, 11391027, 10905585

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

120

Start Date ^†

June 2004

Completion Date

November 2006

Eligibility Criteria ^†

Inclusion Criteria:

Chronic, or acute liver disease
Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to >2.5 mg/dL in less than two weeks.
No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion
Proteinuria <500 mg per day
No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

Exclusion Criteria:

Ongoing shock
Uncontrolled bacterial infection
Current significant fluid losses
Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks)
Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose)
Confirmed pregnancy
Severe cardiovascular disease
Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis)
Participation in other clinical studies within 30 days

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00089570

Organization ID

OT-0401

Secondary IDs ^††

Study Sponsor ^†

Orphan Therapeutics

Collaborators ^††

Investigators ^†

Study Chair:	Arun J. Sanyal, M.D.	Medical College of Virginia, Virginia Commonwealth University Medical Center
Study Director:	Thomas D. Boyer, M.D.	University of Arizona Health Sciences Center
Study Director:	Peter Teuber, Ph.D.	Orphan Therapeutics

Information Provided By

Orphan Therapeutics

Verification Date

October 2006

First Received Date ^†

August 6, 2004

Last Updated Date

October 20, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.