Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1
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ClinicalTrials.gov Identifier: NCT00089570 |
Recruitment Status :
Completed
First Posted : August 9, 2004
Last Update Posted : October 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatorenal Syndrome | Drug: terlipressin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 112 participants |
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 |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Terlipressin
Terlipressin
|
Drug: terlipressin |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo |
- Treatment Success [ Time Frame: Day 14 ]
- Renal function and survival [ Time Frame: Renal funtion to Day 14 and Survival to Day 180 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mallinckrodt |
ClinicalTrials.gov Identifier: | NCT00089570 |
Other Study ID Numbers: |
OT-0401 |
First Posted: | August 9, 2004 Key Record Dates |
Last Update Posted: | October 27, 2017 |
Last Verified: | October 2017 |
hepatorenal syndrome terlipressin |
Hepatorenal Syndrome Syndrome Disease Pathologic Processes Liver Diseases Digestive System Diseases |
Kidney Diseases Urologic Diseases Terlipressin Antihypertensive Agents Vasoconstrictor Agents |