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OpenTrials
Completed

NCT Number: NCT01984788

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

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.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr Marcus Maurer, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key Exclusion Criteria:

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

Treatment and study plan

BCX4161

Drug

Placebo

Drug

Primary outcomes

  1. Number of acute angioedema attacks

    Time frame: Over 28 days of treatment

Secondary outcomes

  1. Incidence and severity of adverse events and laboratory abnormalities

    Time frame: Over 28 days of treatment

  2. Number of attack free days

    Time frame: Over 28 days of treatment

  3. Angioedema Quality of Life scores

    Time frame: Over 28 days of treatment

  4. Angioedema activity scores

    Time frame: Over 28 days of treatment

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema

Acronym: OPuS-1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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