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A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

Study acronym: L47-HD-MN
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 23, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Dec 11, 2025 to May 2026
    • Study completion date: Dec 1, 2029 to Jul 2026
    • Study description expanded, about 26 words
    • Site details revised at 2 of 2 sites
  2. Minor Site details revised at 1 of 2 sitesv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Primary completion date: Dec 1, 2025 to Dec 11, 2025
    • Start date changed from estimate of Dec 1, 2024 to Dec 11, 2024
    v3
  4. Notable Primary completion date: Sep 1, 2024 to Dec 1, 2025
    • Start date: Sep 1, 2024 to Dec 1, 2024
    • Study completion date: Sep 1, 2029 to Dec 1, 2029
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.
Trial Details
NCT Number NCT06505928
Lead Sponsor Shanghai HEP Pharmaceutical Co., Ltd.
Conditions
(from sponsor)
Hepatitis D
Related terms Hepatitis D
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov