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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT06806657
Eligibility Criteria:
Inclusion Criteria:
* Aged \>= 12 years at the time of providing written informed consent / assent.
* Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks.
* Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2:
* Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria),
* C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or
* C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record.
For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an HAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg, or deletion of 72 base pairs \[c.971\_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, OR an HAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutation Lys330Glu), as documented in the participant's medical record; C1INH antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record.
• Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAE and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to Screening.
Exclusion Criteria:
* Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria.
* Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks.
* Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06806657
Study Brief:
Protocol Section:
NCT06806657