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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03576469
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older experiencing ADRs related to IVIG infusions
* Stable dose of IVIG for 3 months
* Willing to comply with all aspects of the protocol, including blood draws
* Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate \< 1% when properly applied and include: a combination oral pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire study period.
Exclusion Criteria:
* Receiving treatment for HAE, either prophylactic or acute therapy
* Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
* Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant.
* Patients who, in the investigator's opinion, might not be suitable for the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03576469
Study Brief:
Protocol Section:
NCT03576469