NCT06806657 Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
| NCT ID | NCT06806657 |
| Status | Active, Not Recruiting |
| Phase | Phase 4 |
| Sponsor | CSL Behring |
| Condition | Hereditary Angioedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2026-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 18 participants in total. It began in 2025-04-28 with a primary completion date of 2026-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein \[KK\] inhibitor or plasma-derived C1-esterase inhibitor \[pdC1INH\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with HAE.
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
CSL Behring
Frequently Asked Questions
Who can join the NCT06806657 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Hereditary Angioedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06806657 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06806657 currently recruiting?
NCT06806657 is currently listed as "Active, Not Recruiting" and is not actively enrolling. Check ClinicalTrials.gov for the latest status updates.
Where is the NCT06806657 trial being conducted?
This trial is being conducted at Litchfield Park, United States, Bentonville, United States, Orange, United States, Santa Monica, United States and 7 additional locations.
Who is sponsoring the NCT06806657 clinical trial?
NCT06806657 is sponsored by CSL Behring. The principal investigator is Study Director at CSL Behring. The trial plans to enroll 18 participants.