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A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorHemab ApS
Started
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Record History

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  1. Eligibility criteria expanded, about 63 words
    • Secondary endpoints: details revised at 32 of 41 entries
    • Site details revised at 15 of 17 sites
  2. Primary and study completion dates: Jun 1, 2026 to Aug 2027
    • Primary endpoints revised (9)
    • Secondary endpoints: 47 to 41
    v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 17
    v5
  4. Study sites revised (18)v4
  5. Study sites: 17 to 18v3
  6. Primary endpoints revised (9)v2 Show 4 more changesShow less
    • Primary and study completion dates: Feb 28, 2026 to Jun 1, 2026
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints revised (47)
    • Study sites revised (17)
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Hemab ApS
5 trials monitored
See 1 trial at risk
The goal of this clinical trial is to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia. The main questions it aims to answer are: * Parts A, B, and C: To determine the safety and tolerability of HMB-001 * Part A: To establish the dose level(s) and dosing interval(s) of HMB-001 to be investigated in Parts B and C * Parts B and C: To estimate the ability of HMB-001 to prevent the number and severity of bleeds Part A will assess differing singular doses of HMB-001 in small groups of participants. The dose administered to a newly enrolled participant (or groups of participants) may only increase if analysis of data from previous dosing shows it is safe to do so. The planned duration of participation in Part A is approximately 6 months, which consists of a Screening Period, an optional Run-in Observation Period, and a follow-up period of 8 weeks. Part B is similar to Part A as it involves testing different dose levels of HMB-001 in small groups of participants. However, in Part B, HMB-001 is given multiple times over a 3-month period, either weekly, every 2 weeks, or every 4 weeks. Part B consists of a Screening Period, a Run-in Observation Period, a 3-month Treatment Period, and a Safety Follow-up following the last dose of HMB-001. Part C is open to participants from Part B and consists of approximately a 18-month Treatment Period and a Safety Follow-up following the last dose of HMB-001.
Trial Details
NCT Number NCT06211634
Lead Sponsor Hemab ApS
Conditions
(from sponsor)		 Glanzmann Thrombasthenia
Related terms Thrombasthenia
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov