Oral Berotralstat Expanded Access Program

December 9, 2020 updated by: BioCryst Pharmaceuticals

Expanded Access Program With Oral Berotralstat for the Prevention of Attacks in Patients With Hereditary Angioedema

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

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

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

Physicians can send email inquiries to access.us@inceptua.com 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

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this program:

  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

Patients must meet none of the below exclusion criteria to be eligible for participation in this program:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX7353-308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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