ClinicalTrials.Veeva

Menu

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema (APeX-1)

BioCryst logo

BioCryst

Status and phase

Completed
Phase 2

Conditions

Hereditary Angioedema (HAE)

Treatments

Drug: BCX7353
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02870972
BCX7353-203

Details and patient eligibility

About

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

Enrollment

75 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • A clinical diagnosis of HAE type I or II
  • Documented HAE attacks within a defined calendar period
  • Access to acute attack medications
  • Sexually active women of child-bearing potential and sexually active men must utilize effective contraception

Key Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
  • Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks
  • History of or current alcohol or drug abuse
  • Infection with hepatitis B, hepatitis C or HIV
  • Participation in any other investigational drug study currently or within the last 30 days

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 5 patient groups, including a placebo group

Part 1: BCX7353 350 mg once daily
Experimental group
Description:
BCX7353 capsules, 350 mg dose administered once per day for 28 days
Treatment:
Drug: BCX7353
Parts 2 and 3: BCX7353 250 mg once daily
Experimental group
Description:
BCX7353 capsules, 250 mg dose administered once per day for 28 days
Treatment:
Drug: BCX7353
Parts 2 and 3: BCX7353 125 mg once daily
Experimental group
Description:
BCX7353 capsules, 125 mg dose administered once per day for 28 days
Treatment:
Drug: BCX7353
Parts 1, 2 and 3: Placebo
Placebo Comparator group
Description:
Placebo capsules, administered once per day for 28 days
Treatment:
Drug: Placebo
Part 3: BCX7353 62.5 mg once daily
Experimental group
Description:
BCX7353 capsules, 62.5 mg dose administered once per day for 28 days
Treatment:
Drug: BCX7353

Trial documents
2

Trial contacts and locations

24

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems