🏛️ Verified NIH Record • Updated 2026-07-24
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease (NCT05045482)
A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Zydus Therapeutics Inc.
🩺 Plain-English Summary (8th-Grade Level)
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
Who can join: Review the eligibility criteria below.
Location: Zydus US002 — Indianapolis, Indiana
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Zydus US002 — Indianapolis, Indiana
📞 Contact the Study Coordinator
Phone: (609) 453-4751
Email: fshaikh@zydustherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatic Impairment
- A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144 — Mesa, Arizona
- A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment — Lake Forest, California
- A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease — Miami Lakes, Florida
- A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234 — Chandler, Arizona
- Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI) — Orlando, Florida
Explore by condition: All Hepatic Impairment clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.