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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT04677803
Eligibility Criteria:
Inclusion Criteria:To be eligible for this study, patients must meet all of the following inclusion criteria:
1. Hereditary bleeding disorder:
* Congenital hemophilia A without inhibitors with a prophylactic treatment regime
* Heterozygous carriers of hemophilia A with subnormal FVIII levels
* VWD Type 1, "Vicenza" type
* VWD Type 2b
2. Male or female, age ≥18-70 years old at Screening
3. If female, must be post-menopausal or surgically sterilized
4. Able to comprehend and to give informed consent
5. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures -
Exclusion Criteria: Patients meeting any of the following criteria will be excluded from the study:
1. Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the patient or compromise the quality of the data derived from his/her participation in this study
2. Medical History of spontaneous (not FVIII or FEIBA-associated) venous or arterial thromboembolic events
3. History of significant drug allergy or anaphylactic reactions
4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the patient to be able to comply fully with study procedures
5. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the patient's welfare or the integrity of the study's results
6. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04677803
Study Brief:
Protocol Section:
NCT04677803