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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04646356
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Clinical HHT diagnosis or personal genetic diagnosis of HHT
3. Epistaxis at least 15 min per week (mean for past month)
4. At least one telangiectasia (skin or mucosal) available for micro-imaging.
5. Ability to give written informed consent, including compliance with the requirements of the study.
Exclusion Criteria:
1. Allergy/intolerance to the study drug or related agents
2. Unstable medical illness
3. Acute infection
4. Creatinine \> ULN (upper limit of normal)
5. Liver transaminases (AST or ALT) \>= 2x ULN
6. Women participant who are pregnant or breastfeeding or plan to become pregnant during the duration of the study
7. Women of childbearing potential not on effective contraception. Male participants of reproductive potential whose female partners are of childbearing potential and are not planning to use highly effective contraceptive method
8. BHCG level \<6 IUL (re-test if 6-24 IU/L)
9. Specific contra-indications for study drug (detailed in the product monograph)
10. Abnormal ECG where the QTc \>480msec
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04646356
Study Brief:
Protocol Section:
NCT04646356