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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT00833703
Eligibility Criteria:
Inclusion Criteria:
* Patients randomized in the CLARINET study,
* Still receiving the study drug,
* Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,
* Investigator's decision to continue based on his/her judgment of the expected benefit / risk of continuing treatment with study drug,
* Signed informed consent to participate in the long-term safety study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT00833703
Study Brief:
Protocol Section:
NCT00833703