- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287664
Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
April 10, 2007 updated by: Hospital Clinic of Barcelona
Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
Hepatorenal syndrome is a common complication of cirrhotic patients.
The prognosis of patients with HRS is very poor.
It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment.
However, previous studies are pilot studies and they are not able to give information about an improvement in survival.
This comparative randomized study was delineated to test the efficacy of terlipressin on survival.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
Phase 3
Study Type
Interventional
Enrollment
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08036
- Hospital Clínic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
- Age between 18 and 75 years
- Written informed consent.
- Absence of exclusion criteria
Exclusion Criteria:
- Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
- Active infection with systemic inflammatory response syndrome
- Respiratory or cardiac dysfunction.
- Arteriopathy.
- Ischemic cardiopathy.
- Arterial hypertension ( >140/90 mmHg during hospitalization )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pere Gines, MD, Chair of Liver Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 6, 2006
First Posted (Estimate)
February 7, 2006
Study Record Updates
Last Update Posted (Estimate)
April 11, 2007
Last Update Submitted That Met QC Criteria
April 10, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAHRS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on terlipressin
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First Affiliated Hospital, Sun Yat-Sen UniversityCompleted
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MallinckrodtCompletedHepatorenal SyndromeUnited States
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Ferring PharmaceuticalsCompletedGastrointestinal Bleeding | Oesophageal VaricesRomania
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Pere GinesUnknownCirrhosis | Hepatorenal Syndrome Type ISpain
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Assaf-Harofeh Medical CenterUnknown
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BioVie Inc.CompletedCirrhosis | Ascites HepaticUnited States
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Aga Khan UniversityFerozsons Laboratories Ltd.CompletedHemorrhage | Portal Hypertension | Esophageal VaricesPakistan
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Aga Khan UniversityMallinckrodtUnknown
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University of PadovaUnknownCirrhosis | Type 1 Hepatorenal SyndromeItaly
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Novartis PharmaceuticalsCompletedCompensated Cirrhosis and Portal HypertensionUnited Kingdom