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Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00089570
First Posted: August 9, 2004
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Orphan Therapeutics
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ]

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
Placebo Comparator: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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:

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
First Submitted: August 6, 2004
First Posted: August 9, 2004
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Orphan Therapeutics:
hepatorenal syndrome
terlipressin

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