A Long Term Safety Study of BCX7353 in Hereditary Angioedema

NCT03472040 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2023-06-18

Study results available
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Summary

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

Conditions

Interventions

DRUG

BCX7353

BCX7353 mg oral capsules administered once daily

Sponsors & Collaborators

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Henriette Farkas, MD · Semmelweis University, Budapest, Hungary

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2022-04-27
Completion
2022-04-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • North Macedonia
  • Poland
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT03472040 on ClinicalTrials.gov