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RECRUITING
NCT06256432
PHASE2

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Sponsor: Noorik Biopharmaceuticals AG

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-04-17

Completion Date

2026-02

Last Updated

2025-01-30

Healthy Volunteers

No

Interventions

DRUG

Ambrisentan

Endothelin receptor antagonist

DRUG

Terlipressin

Terlipressin

Locations (6)

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