Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05045482 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later across 2 updates Mar 31, 2026 → Dec 31, 2026
Primary endpoint reworded 1 of 7 changed
See other at-risk trials from Zydus Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 31, 2026 to Dec 31, 2026v10
  2. Primary endpoint(s) modified
    • Primary and study completion pushed from Mar 31, 2026 to Jul 31, 2026
    v9
  3. Primary and study completion dates: Dec 31, 2025 to Mar 31, 2026v8
  4. Primary and study completion dates: Jun 30, 2025 to Dec 31, 2025v7
  5. Primary and study completion dates: Nov 30, 2024 to Jun 30, 2025
    • Enrollment target: 24 to 30
    • Eligibility criteria expanded, about 18 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Mar 2024 to Nov 30, 2024
    • Study completion date: Jul 2024 to Nov 30, 2024
    • Study site revised
    v5
  2. Primary completion date: Dec 2022 to Mar 2024
    • Study completion date: Apr 2023 to Jul 2024
    v4
  3. Primary completion date: Mar 2022 to Dec 2022
    • Study completion date: May 2022 to Apr 2023
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 2021 to Mar 2022
    • Study completion date: Dec 2021 to May 2022
    • Start date changed from estimate of Sep 2021 to Oct 21, 2021
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
Trial Details
NCT Number NCT05045482
Lead Sponsor Zydus Therapeutics Inc.
Conditions
(from sponsor)		 Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
Related terms Fibrosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov