Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Zydus Therapeutics Inc.
30 participants
Oct 21, 2021
INTERVENTIONAL
Conditions
Summary
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Group-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).
Locations(1)
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NCT05045482