Oral Berotralstat Expanded Access Program

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

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Detailed Description

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Physicians may request access to berotralstat for eligible participants with unmet medical need

Physicians can send email inquiries to [email protected] or call 1-888-225-8677

Patients who may be interested should contact their physician about participation

Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Conditions

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Hereditary Angioedema HAE Prophylaxis

Keywords

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Berotralstat BCX7353 Hereditary Angioedema HAE

Interventions

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Berotralstat

One 150mg capsule administered orally once daily

Intervention Type DRUG

Other Intervention Names

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BCX7353

Eligibility Criteria

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Inclusion Criteria

1. At least 12 years of age
2. Able to provide written, informed consent or assent
3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial
4. Females must use acceptable effective contraception

Exclusion Criteria

1. Pregnancy or breast-feeding
2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BCX7353-308

Identifier Type: -

Identifier Source: org_study_id