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Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

NCT03485911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2023-06-26

Study results available
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Summary

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.

Conditions

Interventions

DRUG

BCX7353 capsules

BCX7353 oral capsules administered once daily

DRUG

Placebo oral capsule

Matching oral capsules administered once daily

Sponsors & Collaborators

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bruce Zuraw, MD · UC San Diego School of Medicine, US HAE Angioedema Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2019-04-10
Completion
2022-04-06
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • North Macedonia
  • Romania
  • 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 NCT03485911 on ClinicalTrials.gov