A Phase 3 interventional study of Sutacimig in Thrombasthenia, sponsored by Hemab ApS. Recruiting at 9 sites in United States. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Hemab ApS · Phase 3, Interventional, and Treatment
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Among 11 studies in Thrombasthenia with a site in United States — 4 open to participants now, 5 under way, 1 of them phase 3. Thrombasthenia · United States.
Among the 11 studies in Thrombasthenia with a site in United States, this one is the only one that started in 2026, is the only one in phase 3, and was the 11th registered.
20 studies on the registry are indexed under Thrombasthenia; 6 are open to participants now.
Browse Thrombasthenia studies →4 of the 11 studies in Thrombasthenia with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
American Thrombosis and Hemostasis Network · Sites in United States
Rockefeller University · Sites in United States
Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Thrombasthenia studies recruiting now, 4 set no upper age limit and 1 stops at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 12 Years to 70 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 4 · Phase 3 1
First in 2004; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 76 is above the median of 28 across 12 interventional studies indexed under Thrombasthenia.
Median enrollment 25 across the 8 interventional studies, 218 across the 3 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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4 of 11 have an industry lead sponsor. The 8 most frequent:
Hemab ApS is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Hemab ApS has 2 studies filed under Thrombasthenia — fewer than ten, so there is no comparison to draw.
2 of the studies in Thrombasthenia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07136857Emory UniversityEptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531) | 2026-12 |
| NCT06211634Hemab ApSA Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia | 2027-08 |
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Among the 11 studies in Thrombasthenia with a site in United States, from their registry updates:
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Glanzmann thrombasthenia (GT) is a serious inherited bleeding disorder. In GT, platelets, the blood cells that normally stick together at the site of an injury to stop bleeding, are unable to properly do so. As a result, bleeding does not stop as it should. Bleeding in GT often starts without warning, can happen frequently, and can be severe. It most commonly affects the nose, mouth and gums, gastrointestinal tract, and skin, and many women and girls with GT experience heavy menstrual bleeding. Over time, bleeding can lead to iron deficiency and anemia. Some bleeding episodes require emergency care, hospitalization, transfusion, or surgery, and some can be life-threatening.
Sutacimig is an investigational medicine given as an injection under the skin (subcutaneous injection). It is designed to help platelets work at the site of bleeding despite the underlying defect in GT. It is intended to be given regularly to help prevent bleeding (prophylaxis), rather than only to treat bleeding after it starts.
The purpose of this study is to find out whether sutacimig, given as prophylaxis, reduces the number of treated bleeding episodes in people with GT compared with no prophylaxis, and to evaluate its safety and tolerability.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has clinical bleeding phenotype consistent with Glanzmann thrombasthenia (GT) and documentation of either diagnostic laboratory criteria (a) or (b) below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive sutacimig 0.2 milligrams per kilogram (mg/kg) by subcutaneous injection once weekly for 48 weeks. Upon completion of the 48-week treatment period, participants will be offered the opportunity to transition to a separate open-label extension (OLE) study for continued assessment of the prophylactic treatment with sutacimig.
Drug: Sutacimig
Sutacimig will be administered by subcutaneous injection.
Annualized Treated Bleed Rate (ATBR)
Time frame: From the first dose through Week 48
High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
Time frame: From the first dose through Week 48
Annualized Treated Bleed Days (ATBD)
Time frame: From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Type
Time frame: From the first dose through Week 48
Annualized Treated Bleed Rate (ATBR) by Bleeding Event Cause
Time frame: From the first dose through Week 48
Percentage of Participants With Reductions in Annualized Treated Bleed Rate (ATBR)
Time frame: From the first dose through Week 48
Percentage of Participants With Reductions in High-Intensity Annualized Treated Bleed Rate (Hi-ATBR)
Time frame: From the first dose through Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dose through Week 56
Number of Participants With Physical Examination Abnormalities
Time frame: From the first dose through Week 56
Number of Participants With Vital Sign Abnormalities
Time frame: From the first dose through Week 56
Number of Participants With Clinical Laboratory Test Abnormalities
Time frame: From the first dose through Week 56
Number of Participants With Anti-Drug Antibody (ADA) Development
Time frame: From the first dose through Week 56
Number of Participants With Changes in Electrocardiogram (ECG) Parameters
Time frame: From the first dose through Week 56
Plasma Concentration for Sutacimig
Time frame: Baseline through Week 56
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Nov 2029, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hemab ApS