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Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Study sites: 35 to 23
    • Study title revised
    • Study description shortened, about 1 word
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 35
    • Start date changed from estimate of Jun 20, 2023 to Aug 12, 2023
    v3
  4. Eligibility criteria shortened, about 1 wordv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
Trial Details
NCT Number NCT05905172
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Conditions
(from sponsor)		 Liver Fibrosis
Related terms Liver Cirrhosis
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov