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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT02170402
Eligibility Criteria:
Main Inclusion Criteria:
* Ethnic Chinese
* is of any age
* has a documented diagnosis of severe or moderately severe hemophilia A (congenital FVIII deficiency: baseline Factor VIII (FVIII) ≤ 2%)
* has documented and verified \>50 exposure days (EDs) to FVIII (recombinant or plasma derived)
* is receiving on-demand treatment with FVIII at the time of enrolment in this study
* has negative history of inhibitor development
* is HIV negative or HIV positive with stable disease and CD4+ count ≥ 200 cells per mm\^3
* is negative for Hepatitis C virus (HCV); Or participant is HCV positive with chronic stable hepatitis as assessed by investigator
Main Exclusion Criteria:
* has prior history of hypersensitivity or anaphylaxis associated with receipt of FVIII
* is diagnosed with other bleeding disorder(s) other than hemophilia A, including but not limited to thrombocytopenia (platelet count \< 100000 /mL)
* has been exposed to an investigational product (IP) within 30 days prior to the screening visit or is scheduled to participate in another clinical study involving an IP or investigational device during participation in the study
* is planned, or likely to have surgery during the study period
* has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator
* has active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 5 times the upper limit of normal)
* has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent \& persistent international normalized ratio (INR) \>1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices
* is a family member of the investigator or site staff
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02170402
Study Brief:
Protocol Section:
NCT02170402