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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR BEROTRALSTAT HYDROCHLORIDE


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All Clinical Trials for berotralstat hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03485911 ↗ Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE Active, not recruiting BioCryst Pharmaceuticals Phase 3 2018-02-06 This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
NCT04933721 ↗ Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies Not yet recruiting BioCryst Pharmaceuticals Phase 3 2021-06-01 This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.
NCT05392114 ↗ A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) Not yet recruiting Ionis Pharmaceuticals, Inc. Phase 3 2022-05-01 The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
NCT05453968 ↗ Berotralstat Treatment in Children With Hereditary Angioedema Not yet recruiting BioCryst Pharmaceuticals Phase 3 2022-07-01 The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years old for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for berotralstat hydrochloride

Condition Name

Condition Name for berotralstat hydrochloride
Intervention Trials
Hereditary Angioedema 4
HAE 2
Pediatric 1
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Condition MeSH

Condition MeSH for berotralstat hydrochloride
Intervention Trials
Angioedemas, Hereditary 4
Angioedema 4
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Clinical Trial Locations for berotralstat hydrochloride

Trials by Country

Trials by Country for berotralstat hydrochloride
Location Trials
United States 19
Canada 3
North Macedonia 2
Austria 2
France 2
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Trials by US State

Trials by US State for berotralstat hydrochloride
Location Trials
Massachusetts 1
Maryland 1
Florida 1
Colorado 1
California 1
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Clinical Trial Progress for berotralstat hydrochloride

Clinical Trial Phase

Clinical Trial Phase for berotralstat hydrochloride
Clinical Trial Phase Trials
Phase 3 4
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Clinical Trial Status

Clinical Trial Status for berotralstat hydrochloride
Clinical Trial Phase Trials
Not yet recruiting 3
Active, not recruiting 1
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Clinical Trial Sponsors for berotralstat hydrochloride

Sponsor Name

Sponsor Name for berotralstat hydrochloride
Sponsor Trials
BioCryst Pharmaceuticals 3
Ionis Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for berotralstat hydrochloride
Sponsor Trials
Industry 4
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