Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Sponsor
BioCryst Pharmaceuticals
Study ID
NCT04933721
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • berotralstat — DRUG
    BCX7353 capsules or granules administered orally once daily

Study Details

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.

Key Dates

Start date
Jul 23, 2021
Status verified
Dec 2025
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
139 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: BCX7353 capsules or granules once daily
    Berotralstat (BCX7353) capsules or granules orally administered once daily.

Primary Outcome Measure

Number and proportion of subjects with a treatment-related TEAE [ Time Frame: 240 weeks ]

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