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A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Bluejay Therapeutics, Inc. to Mirum Pharmaceuticals, Inc.
    • Site details revised at 7 of 38 sites
    v10
  2. Primary completion date: Jun 2027 to May 2029
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2028 to Sep 2029
    • Site details revised at 38 of 38 sites
    v9
  3. Study sites: 36 to 38v8
  4. Study sites: 32 to 36v7
  5. Study sites: 26 to 32v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 18 to 26v5
  2. Study sites: 13 to 18v4
  3. Study sites: 6 to 13v3
  4. Study sites: 4 to 6v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Trial Details
NCT Number NCT06907290
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Chronic Hepatitis D Infection
Related terms Hepatitis D
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov