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New treatment option for Glanzmann Thrombasthenia
Official title Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)
ClinicalTrials.gov ID: NCT07136857
What this study is testing
What is EPTACOG BETA?
EPTACOG BETA is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for glanzmann thrombasthenia.
Also referred to as SEVENTFACT®; EB.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is evaluating an investigational drug, eptacog beta (EB), for the treatment and prevention of acute bleeding episodes in people with Glanzmann Thrombasthenia, a rare inherited bleeding disorder. Eptacog beta (EB) is not currently approved by the U.S.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Adult or Pediatric persons with inherited Glanzmann thrombasthenia (see diagnostic criteria below)
- Severe bleeding phenotype
- Adequate hepatic function
- Adequate renal function
- Adults subject (≥18 years of age) or caregiver (parent or legally authorized representative) for minor people, people with cognitive impairment, or...
You likely can't join if
- Thrombocytopenia (platelet count \< 100k)
- Acquired Glanzmann thrombasthenia secondary to autoimmune disease, malignancy, or medication
- Inherited or acquired bleeding diathesis other than Glanzmann thrombasthenia
- Have a history of venous or arterial thrombotic event within 2 years of study enrollment
- Active malignancy
- Known or suspected hypersensitivity to rabbits, rabbit protein, other forms of rFVIIa, or to any of the EB excipients
See the full eligibility criteria
- Adult or Pediatric persons with inherited Glanzmann thrombasthenia (see diagnostic criteria below)
- Severe bleeding phenotype
- Adequate hepatic function
- Adequate renal function
- Adults subject (≥18 years of age) or caregiver (parent or legally authorized representative) for minor people, people with cognitive impairment, or people with impaired decision-making capacity have provided written...
- Ability to speak, read, and understand the English language
- Thrombocytopenia (platelet count \< 100k)
- Acquired Glanzmann thrombasthenia secondary to autoimmune disease, malignancy, or medication
- Inherited or acquired bleeding diathesis other than Glanzmann thrombasthenia
- Have a history of venous or arterial thrombotic event within 2 years of study enrollment
- Active malignancy
- Known or suspected hypersensitivity to rabbits, rabbit protein, other forms of rFVIIa, or to any of the EB excipients
- Have received an investigational drug within 30 days or within 5 half-lives of that investigational drug (whichever is longer) or are expected to receive such a drug during participation in this study
- Be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitor properties for the duration of the study
- Be using or administered anticoagulant agents for the duration of the study
- Have any life-threatening disease or other disease or condition which, according to the investigator's judgement, could imply a potential hazard to the patient, or interfere with the study participation or study outcome
- Use of systemic immunomodulators at enrollment or planned use during the study
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.