A Study Assessing HMB-002 in Participants With Von Willebrand Disease
Recruiting now · Phase 1/Phase 2
Conditions studied: Von Willebrand Disease (VWD), Von Willebrand Disease (VWD), Type 1, Von Willebrand Disease (VWD), Type 2, Von Willebrand Disease (VWD), Type 3
In brief
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.
Key facts
- Study ID
- NCT06754852
- Run by
- Hemab ApS
- People needed
- 108
- Starts
- 2025-02-06
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-30
Who can join
Age: 16 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- University Hospital of Wales — Cardiff, United Kingdom (enrolling)
- Basingstoke and North Hampshire Hospital — Basingstoke, Hampshire, United Kingdom (enrolling)
- Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States (enrolling)
- Richmond Pharmacology — London, United Kingdom (enrolling)
- Royal Prince Alfred Hospital — Camperdown, Sydney, Australia (enrolling)
- University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders — Ann Arbor, Michigan, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Hemophilia Center of Western Pennsylvania — Pittsburgh, Pennsylvania, United States
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Washington Institute For Coagulation (WIC) — Seattle, Washington, United States
- Fiona Stanley Hospital — Murdoch, Perth, Australia
- St George's Hospital — Tooting, London, United Kingdom
- Royal London Hospital — Whitechapel, London, United Kingdom
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
- St James's University Hospital, Leeds Haemophilia Centre — Leeds, United Kingdom
- Royal Liverpool and Broadgreen University Hospitals NHS TRUST, The Roald Dahl Haemostasis and Thrombosis Centre — Liverpool, United Kingdom
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- St Thomas' Hospital — London, United Kingdom
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Children's Hospital of Los Angeles — Los Angeles, California, United States
- University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Tulane University School of Medicine — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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