Hereditary angioedema Haematological Disorders
Conditions
Interventions
Adult participants will receive one of three dosing regimens:
Regimen 1: Participants will receive 600 mg of navenibart (STAR-0215) via subcutaneous injection every 3 months.
Regimen 2: Participants
Sponsors
Astria Therapeutics, Inc (USA)
Eligibility
Sex/Gender
All
Age
12 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. 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 and met all of 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
Exclusion criteria: 1. 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 2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 30 days before informed consent/assent. 3. Known sensitivity to the ingredients in the formulation of IP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events measured using patient records at first dosing visit through final follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| First dosing visit through final follow-up visit measured using patient records: 1. Number of time-normalized investigator-confirmed HAE attacks 2. Number of moderate or severe investigator-confirmed HAE attacks 3. Number of investigator-confirmed HAE attacks that require on-demand treatment 4. Percent reduction in monthly investigator-confirmed HAE attacks 5. Time to first investigator-confirmed HAE attack after first dose 6. The number of participants responding to treatment, defined as a = 50%, = 70%, or = 90% reduction in investigator-confirmed HAE attack rate 7. Number of participants with no investigator-confirmed HAE attacks 8. Angioedema Quality of Life (AE-QoL) questionnaire total score | — |
Countries
Australia, Austria, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, South, Netherlands, New Zealand, North Macedonia, Poland, Portugal, South Africa, Spain, United Kingdom, United States of America
Contacts
Public Contact. Clinical Trial Inquiries
Outcome results
None listed