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ACTIVE NOT RECRUITING
NCT05453968
PHASE3

Berotralstat Treatment in Children With Hereditary Angioedema

Sponsor: BioCryst Pharmaceuticals

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2022-10-25

Completion Date

2027-02

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Berotralstat

Administered orally once daily

Locations (15)

Investigative Site #1

Vienna, Ontario, Austria

Investigative Site #1

Ottawa, Ontario, Canada

Investigative Site #3

Grenoble, France

Investigative Site #2

Marseille, France

Investigative Site #1

Paris, France

Investigative Site #1

Berlin, Germany

Investigative Site #2

Frankfurt, Germany

Investigative Site #2

Haifa, Israel

Investigative Site #1

Tel Aviv, Israel

Investigative Site #1

Padova, Italy

Investigative Site #1

Krakow, Poland

Investigative Site #1

Sângeorgiu de Mureş, Romania

Investigative Site #1

Madrid, Spain

Investigative Site #2

Málaga, Spain

Investigative Site #1

Bristol, United Kingdom