Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orphan Therapeutics
ClinicalTrials.gov Identifier:
NCT00089570
First received: August 6, 2004
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Hepatorenal Syndrome
Drug: terlipressin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1

Resource links provided by NLM:


Further study details as provided by Orphan Therapeutics:

Primary Outcome Measures:
  • Treatment Success [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2004
Study Completion Date: September 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terlipressin
Terlipressin
Drug: terlipressin
Other Name: terlipressin
Placebo Comparator: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089570

  Show 37 Study Locations
Sponsors and Collaborators
Orphan Therapeutics
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orphan Therapeutics
ClinicalTrials.gov Identifier: NCT00089570     History of Changes
Other Study ID Numbers: OT-0401
Study First Received: August 6, 2004
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Orphan Therapeutics:
hepatorenal syndrome
terlipressin

Additional relevant MeSH terms:
Hepatorenal Syndrome
Syndrome
Digestive System Diseases
Disease
Kidney Diseases
Liver Diseases
Pathologic Processes
Urologic Diseases
Lypressin
Terlipressin
Antidiuretic Agents
Antihypertensive Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014