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A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 53 → 57 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 9 of 17 entries
  2. Trial sites expanded: 48 → 53 locationsv8
  3. Trial sites expanded: 44 → 48 locationsv7
  4. Study sites: 40 to 44v6
  5. Lead sponsor: Bluejay Therapeutics, Inc. to Mirum Pharmaceuticals, Inc.
    • Study sites: 20 to 40
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 17 to 20v4
  2. Study sites: 12 to 17v3
  3. Study sites: 4 to 12v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
Trial Details
NCT Number NCT07200908
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Chronic Hepatitis D Infection
Related terms Hepatitis D
Enrollment 172 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov