This trial is active, not recruiting.

Condition hereditary angioedema
Treatments bcx4161, placebo
Phase phase 2
Sponsor BioCryst Pharmaceuticals
Start date November 2013
End date June 2014
Trial size 25 participants
Trial identifier NCT01984788, BCX4161-203


The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
400 mg TID for 28 days
(Placebo Comparator)
TID for 28 days

Primary Outcomes

Number of acute angioedema attacks
time frame: Over 28 days of treatment

Secondary Outcomes

Incidence and severity of adverse events and laboratory abnormalities
time frame: Over 28 days of treatment
Number of attack free days
time frame: Over 28 days of treatment
Angioedema Quality of Life scores
time frame: Over 28 days of treatment
Angioedema activity scores
time frame: Over 28 days of treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Key Inclusion Criteria: - Written informed consent - Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II - An average angioedema attack frequency of 1/week - Acceptable birth control measures Key Exclusion Criteria: - Concurrent use of defined treatments for prophylaxis - Pregnancy or breast-feeding - Clinically significant medical condition, laboratory abnormality or medical history

Additional Information

Official title A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
Principal investigator Marcus Maurer, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by BioCryst Pharmaceuticals.