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HepB mAb19 in Individuals With Chronic Hepatitis B Infection

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Start date: Aug 7, 2023 to Apr 25, 2024 Show 7 more changesShow less
    • Primary endpoints: details revised at 2 of 14 entries
    • Enrollment closed, study ongoing
    • Primary completion moved earlier from Dec 1, 2027 to Jul 7, 2027
    • Study completion pushed from Mar 30, 2028 to Dec 30, 2028
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv11
  3. Primary completion date: Mar 30, 2027 to Dec 1, 2027
    • Study completion date: Mar 30, 2027 to Mar 30, 2028
    • Start date: Apr 1, 2024 to Aug 7, 2023
    • Site contacts updated at 1 of 2 sites
    v10
  4. Primary completion date: Dec 1, 2027 to Mar 30, 2027
    • Study completion date: Mar 30, 2028 to Mar 30, 2027
    • Site contacts updated at 1 of 2 sites
    v9
  5. Primary completion date: Mar 30, 2027 to Dec 1, 2027
    • Start date: Aug 7, 2023 to Apr 1, 2024
    • Study completion date: Sep 30, 2027 to Mar 30, 2028
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria shortened, about 7 wordsv7
  2. Primary completion date: May 15, 2026 to Mar 30, 2027
    • Study completion date: May 15, 2026 to Sep 30, 2027
    v6
  3. Site details revised at 1 of 2 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2023 to Aug 7, 2023
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 3 words
    v4
  5. Start date: Jun 1, 2023 to Aug 1, 2023v3
  6. Interventions: HepB mAb19 or Placebo (Biological) to HepB mAb19 (Biological), Sterile Saline (Other)
    • Study arms: 5 to 9
    • Study title shortened, about 3 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
Trial Details
NCT Number NCT05856890
Lead Sponsor Rockefeller University
Collaborators: NYU Langone Health
Conditions
(from sponsor)		 Hepatitis b Virus, Hepatitis B
Related terms Hepatitis B
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov