OPuS-2 - Preventing HAE attacks
Research type
Research Study
Full title
OPuS-2 A multicentre, randomised, double blind, placebo controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX4161 for 12 weeks as an oral prophylaxis treatment for attacks of hereditary angioedema.
IRAS ID
169816
Contact name
Desiree Clemons
Contact email
Sponsor organisation
BioCryst Pharmaceuticals Inc
Eudract number
2014-002655-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
GENE 3982, CCRN
Duration of Study in the UK
0 years, 8 months, 16 days
Research summary
Hereditary angioedema (HAE) is an autosomal dominant disorder characterized by periodic episodes of swelling of the skin, pharynx, larynx, gastrointestinal tract, genitals, and extremities. The frequency of these attacks varies between subjects, with attacks occurring rarely in some patients to as frequently as every few days in others. HAE attacks, which may or may not be precipitated by a stimulus (such as stress, trauma, or estrogen) are typically slow in onset, peaking in intensity within 24 hours, and gradually subside over the subsequent 5 days. This study will further assess the ability of a novel compound BCX4161 to prevent these attacks. In OPuS-1, the 28-day proof-of-concept study of BCX4161 in subjects with frequent HAE attacks there was a reduction across all subjects of 0.45 attacks per week on BCX4161. OPuS-2 expands upon the scope of OPuS-1 by evaluating the safety and efficacy of BCX4161 administered at two doses over a longer duration in a greater number of subjects with a wider range of attack frequencies. Patients will complete electronic diaries to document the attacks they have and how they treat them. Patients will be allowed to treat their attacks as per normal clinical practice, without restriction.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/0034
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion