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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01147302
Eligibility Criteria:
Inclusion Criteria include:
* ≥18 years of age.
* Weigh ≥50 kg.
* Donor specific antibody identified.
Exclusion Criteria include:
* Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
* History of allergic reaction to C1 Esterase Inhibitor or other blood products.
* Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with study drug.
* Pregnancy or lactation.
* Receipt of any experimental agents for AMR within 1 month prior to the first dose of study drug.
* Any infection that causes hemodynamic compromise.
* History of bleeding or clotting abnormality.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01147302
Study Brief:
Protocol Section:
NCT01147302