At a glance
ClinicalIndex Comparison RecordPhase 3Active· 29 enrolled
Drug / intervention
Berotralstatdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study to Evaluate the Safety and Pharmacokinetics of Berotralstat Prophylaxis in Children With Hereditary Angioedema Who Are 2 to < 12 Years of Age
In Brief
A Phase 3 clinical trial evaluating Berotralstat for Hereditary Angioedema and Pediatric. Active but no longer recruiting, targeting 29 participants across 15 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and effectiveness of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to \< 12 years of age for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema, Pediatric
CountriesAustria, Canada, France, Germany, Israel, Italy, Poland, Romania, Spain, United Kingdom
Collaborators--
Timeline
Phase 3Active
20232024202520262027
First PostedJul 2022
Enrollment StartOct 2022
Primary CompletionSep 2024
TodayJul 2026
Study CompletionFeb 2027
First PostedJul 12, 2022
Enrollment StartOct 25, 2022
Primary CompletionSep 11, 2024
Study CompletionFeb 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.0 years ago
Interventions
Berotralstatdrug
Administered orally once daily