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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03935334
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of congenital hemophilia A or B with inhibitors to FVIII or FIX titer \>5 Bethesda Units (BU)
* with \> 2 episodes of bleeding/year requiring treatment with FVII infusions, non in bleeding status
* male subjects
* adult and children (\>12 years)
* written informed consent to the protocol to be eligible for the study. For minor patients, parent/legal guardian will provide consent and, when possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent.
* For the PK/PD phase, patients will be hospitalized at the time of study medication administration for plasma sampling (2 times during the study).
Exclusion Criteria:
* Any other type of congenital or acquired coagulopathy, such as liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
* Antibodies against Factor VII
* Ongoing bleeding prophylaxis regimens with Novoseven or planned to occur during the trial
* Patients who have received routine (prophylactic) treatment with rFVIIa in the period between screening visit (visit 1) and visit 2 of this study (first dose administration)
* Platelet count less than 100.000 platelets/microliter (at screening visit)
* Any clinical sign or known history of an arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
* HIV positive with current CD4+ count of less than 200/µL
* Liver cirrhosis
* Factor VIII/IX immune tolerance induction regimen planned to occur during the trial
* Known hypersensitivity to the study medication
* Parallel participation in another experimental drug trial.
* Parallel participation in another marketed drug trial that may affect the primary endpoint of the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Study:
NCT03935334
Study Brief:
Protocol Section:
NCT03935334