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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00927667
Eligibility Criteria:
Inclusion Criteria:
* Males aged 12 - 35 years
* Severe hemophilia A ( \< 1 % FVIII:C)
* No history of Factor VIII inhibitory antibody
* For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
* Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
* Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
* For the on-demand subjects \> 12 bleeds/year in the last 5 years.
* Written informed consent by subject and parent/legal representative, if \< 18 years
Exclusion Criteria:
* Individuals with other coagulopathies (e.g., von Willebrand disease)
* HIV seropositive subjects
* Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
* HCV seropositive individuals who underwent interferon therapy during the last 12 months
* Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
* Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period
* Joint replacement
* For the on-demand treatment group, any period greater than 8 consecutive months having received \>/= 50 IU per kg per week Factor VIII for the prevention of bleeding
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT00927667
Study Brief:
Protocol Section:
NCT00927667