Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03485911

Hereditary Angioedema HAE

COMPLETED PHASE3

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

NCT02303626

Hereditary Angioedema HAE

COMPLETED PHASE2/PHASE3

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

NCT02870972

Hereditary Angioedema (HAE)

COMPLETED PHASE2

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

NCT03472040

Hereditary Angioedema HAE Prophylaxis

COMPLETED PHASE2/PHASE3

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

NCT03240133

Hereditary Angioedema (HAE)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hereditary Angioedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BCX4161

400 mg TID for 28 days

Group Type ACTIVE_COMPARATOR

BCX4161

Intervention Type DRUG

Placebo

TID for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BCX4161

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

* Concurrent use of defined treatments for prophylaxis
* Pregnancy or breast-feeding
* Clinically significant medical condition, laboratory abnormality or medical history

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No