- Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06679881.
- What is being tested: Once-daily oral deucrictibant extended-release tablet as a preventative treatment to reduce angioedema attack frequency in patients with hereditary angioedema (HAE), assessed for long-term safety and efficacy in a Phase 3 trial.
- Patient eligibility overview: Adolescents and adults aged 12 years and older with confirmed hereditary angioedema are eligible for this open-label study.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
- : 1. Provision of the signed ICF by the participant and/or legally designated representative. 2. Male or female, aged ≥12 years at the time of providing written informed consent/assent. 3. Diagnosis of hereditary angioedema (HAE) 4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening 5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks. 6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording. 7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.