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A Study Assessing HMB-002 in Participants With Von Willebrand Disease

StatusRecruiting
PhasePhase 1/2
SponsorHemab ApS
Started
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Record History

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  1. Study sites: 4 to 25v4 Show 4 more changesShow less
    • Interventions: HMB-002 (Part A) (Drug), HMB-002 (Part B) (Drug) to HMB-002 (Part A) (Drug), HMB-002 (Part B) (Drug), HMB-002 with Concomitant Factor Concentrate (Part C) (Not Applicable in US) (Drug)
    • Eligibility criteria shortened, about 84 words
    • Secondary endpoints: 8 to 9
    • Study arms: 2 to 3
  2. Study sites: 1 to 4
    • Eligibility criteria expanded, about 115 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2025 to Feb 6, 2025
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a first-in-human (FIH), Phase 1/2, 3-part open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study evaluating HMB-002 in participants with VWD. Part A of the study involves a single ascending dose (SAD) regimen design to establish safety, tolerability, PK, and PD effect. In Part B of the study, the safety and tolerability of repeat dosing will be established prior to cohort expansion to explore efficacy. Part C will evaluate the safety, PK, and PD of a single concomitant dose of HMB-002 and factor concentrate with Type 3 VWD or Type 1 VWD with low residual VWF and FVIII who use factor concentrate as prophylaxis.
Trial Details
NCT Number NCT06754852
Lead Sponsor Hemab ApS
Conditions
(from sponsor)		 Von Willebrand Disease (VWD), Von Willebrand Disease (VWD), Type 1, Von Willebrand Disease (VWD), Type 2, Von Willebrand Disease (VWD), Type 3
Related terms von Willebrand Disease, Type 3, von Willebrand Diseases
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov