jRCT2071260041RecruitingNot Applicable
A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema (ORBIT-EXPANSE)
Not provided0 sites11 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 11
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 12age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Participants from STAR-0215-301 who met one of the following conditions:
- •a. Completed STAR-0215-301 through the Day 181 visit
- •b. Withdrew from STAR-0215-301 but met the following criteria:
- •i. Received 2 doses of IP ii. completed >= 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
Exclusion Criteria
- •Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent
- •Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening.
- •Known sensitivity to the ingredients in the formulation of IP
Investigators
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