A trial to learn about a study drug (STAR-0215) in adults with hereditary angioedema
- Conditions
- Hereditary angioedema (HAE)Circulatory System
- Registration Number
- ISRCTN99457796
- Lead Sponsor
- Astria Therapeutics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 29
1. Documented diagnosis of HAE (type I or II). The following must be met: Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
2. Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
2.1. lanadelumab within 90 days
2.2. berotralstat within 21 days
2.3. all other prophylactic therapies, within 7 days
3. Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening.
4. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants Experiencing Treatment-emergent Adverse Events [ Time Frame: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), and Day 475 (Cohort 3)<br>
- Secondary Outcome Measures
Name Time Method