Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-02-29

Brief Summary

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This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

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Detailed Description

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Conditions

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Hereditary Angioedema HAE

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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avoralstat

Five avoralstat capsules (100 mg) to be taken three times daily by mouth

Group Type EXPERIMENTAL

avoralstat

Intervention Type DRUG

Interventions

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avoralstat

Intervention Type DRUG

Other Intervention Names

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BCX4161

Eligibility Criteria

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Inclusion Criteria

* Males and non-pregnant, non-lactating females age ≥ 18 years.
* Provide written, informed consent.
* Prior completion of an avoralstat therapeutic study OR a confirmed diagnosis of HAE Type 1 or HAE Type 2.
* Access to appropriate medication for the treatment of acute HAE attacks.
* Adequate contraception.

Exclusion Criteria

* Females who are pregnant or breast feeding.
* Clinically significant medical condition or medical history.
* Abnormal screening ECG, laboratory or urinalysis finding that is clinically significant.
* Investigational drug exposure within 30 days (except avoralstat).
* History of or current alcohol or drug abuse.
* HIV or active HBV or HCV infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No