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

NCT04933721 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-12-23

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

berotralstat

BCX7353 capsules or granules administered orally once daily

Sponsors & Collaborators

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Vesna Grivcheva-Panoska, MD, PhD · PHI University Clinic of Dermatology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2031-08-31
Completion
2031-08-31
FDA Drug
Yes

Countries

  • Canada
  • Czechia
  • France
  • Germany
  • North Macedonia
  • Poland
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933721 on ClinicalTrials.gov