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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT05856266
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 6 years
2. Diagnosis of haemophilia A or B
3. Having at least 6 months documented pre-study treatment data regarding treatment prescriptions and bleeding episodes prior to the baseline visit
4. Previous treatment for haemophilia A or B with any marketed recombinant and/or plasma-derived FVIII or FIX concentrate for at least 6 months
5. Start of prophylactic treatment with rFVIIIFc or rFIXFc prior to study enrollment or latest at the baseline visit, in accordance with local regulations
6. Signed and dated informed consent provided by the patient, or the patient's legally authorized representative for patients under the legal age. Assent should be obtained from paediatric patients in accordance with local regulations
Exclusion Criteria:
1. Any medical condition which in the opinion of the investigator makes the subject patient unsuitable for inclusion
2. Prophylactic treatment with non-factor therapy during the 6 months prior to enrolment
3. Presence of factor VIII or FIX inhibitory antibodies (inhibitors) (≥0.60 Bethesda Units \[BU\]/mL) at the latest available inhibitor test
4. Enrolment in a concurrent clinical interventional study, or intake of an IMP, within three months prior to inclusion in this study
5. Foreseeable inability to cooperate with given instructions or study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05856266
Study Brief:
Protocol Section:
NCT05856266