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NCT04428632 Clinical Trial

Oral Berotralstat Expanded Access Program

Hereditary Angioedema Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04428632
Other study ID # BCX7353-308
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date December 2020
Source BioCryst Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Berotralstat
One 150mg capsule administered orally once daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BioCryst Pharmaceuticals
See also
  Status Clinical Trial Phase
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Completed NCT00997204 - EASSI - Evaluation of the Safety of Self-Administration With Icatibant Phase 3
Completed NCT00438815 - Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks Phase 3
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Completed NCT01426763 - A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase Phase 2
Terminated NCT04091113 - Hereditary Angioedema Kininogen Assay
Completed NCT00432510 - Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects Phase 1
Completed NCT03712228 - A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) Phase 2
Active, not recruiting NCT05453968 - Berotralstat Treatment in Children With Hereditary Angioedema Phase 3
Recruiting NCT05511922 - PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial Phase 3
Recruiting NCT05505916 - An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
Completed NCT01984788 - Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE Phase 2
Completed NCT04888650 - Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Completed NCT02448264 - First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers Phase 1
Completed NCT05118958 - Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations Phase 1
Completed NCT06414252 - Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Active, not recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
Completed NCT02819102 - An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates Phase 1