Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT07136857
Eligibility Criteria:
Inclusion 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 subjects, subjects with cognitive impairment, or subjects with impaired decision-making capacity have provided written informed consent, and the participant has given consent/assent (if applicable)
* Ability to speak, read, and understand the English language
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07136857
Study Brief:
Protocol Section:
NCT07136857