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A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome
Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death. The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses. This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome. The main questions the clinical trial aims to answer are: * Does ambrisentan help the kidney function of the patient? * Does ambrisentan help prevent death in patients with Hepatorenal Syndrome? * Does ambrisentan prevent Hepatorenal Syndrome from reappearing? While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Aster CMI Hospital
Bangalore, Karnataka, India
Sir HN Reliance Hospital Foundation
Mumbai, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Asian Institute of Gastroenterology (AIG)
Hyderabad, Telangana, India
Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College
Kanpur, Uttar Pradesh, India
Medanta Multi Super Specialty Hospital
Lucknow, Uttar Pradesh, India
Start Date
April 17, 2024
Primary Completion Date
December 1, 2025
Completion Date
February 1, 2026
Last Updated
January 30, 2025
54
ESTIMATED participants
Ambrisentan
DRUG
Terlipressin
DRUG
Lead Sponsor
Noorik Biopharmaceuticals AG
NCT05806645
NCT07472426
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07447791