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NCT06211634 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia
A Phase 1 study of Glanzmann Thrombasthenia, sponsored by Hemab ApS.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 17
- Study locations
NCT06211634 is a Phase 1 study of Glanzmann Thrombasthenia that is active but no longer recruiting, run by Hemab ApS. The registered enrollment target is 57 participants. The trial reports 17 study locations across 6 states.
The verdict
NCT06211634, a Phase 1 study of Glanzmann Thrombasthenia, is active but no longer recruiting, sponsored by Hemab ApS.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 17
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG HMB-001
Study Locations (17)
Other
- University Hospital Leuven - Campus Gasthuisberg (Part B/C) - Leuven
- AP-HP Hopital Bicetre (Part B/C) - Le Kremlin-Bicêtre
- AP-HM - Hopital de la Timone - Marseille
- AP-HP Hopital Necker-Enfants Malades (Part B/C) - Paris
- Azienda Ospedaliero-Universitaria Careggi (Part B/C) - Florence
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano (Part B/C) - Milan
- Universitair Medisch Centrum Utrecht (Part B/C) - Utrecht
- Queen Elizabeth Hospital Birmingham (Part B/C) - Birmingham
- Leeds Teaching Hospitals NHS Trust - Leeds
- Richmond Pharmacology Ltd (Part A/B/C) - London
- Royal Free London NHS Foundation Trust (Part B/C) - London
- The Royal London Hospital (Part B/C) - Whitechapel
California
- University of California, San Diego (UCSD) (Part B/C) - La Jolla
Louisiana
- Tulane University Medical Center (Part B/C) - New Orleans
Minnesota
- Mayo Clinic - Rochester (Part B/C) - Rochester
Pennsylvania
- Hemophilia Center of Western Pennsylvania (HCWP) (Part B/C) - Pittsburgh
Washington
- Washington Institute for Coagulation (Part B/C) - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06211634
The ClinicalTrials.gov registry entry for NCT06211634 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemab ApS, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glanzmann Thrombasthenia appearing as the primary indexed condition, and to 1 intervention - of which HMB-001 is the first listed.
NCT06211634 reports 17 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06211634 about?
NCT06211634 is a clinical study titled "A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia". 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 ...
What is the current status of trial NCT06211634?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2022-12-13. Estimated completion is 2027-08.
What conditions does trial NCT06211634 study?
This clinical trial studies the following conditions: Glanzmann Thrombasthenia.
What interventions are being tested in trial NCT06211634?
The interventions under investigation include: HMB-001 (DRUG).
Who is sponsoring clinical trial NCT06211634?
This trial is sponsored by Hemab ApS, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06211634 being conducted?
This trial has 17 study locations across California, Louisiana, Minnesota, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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