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Trial record 3 of 5 for:    bcx4161

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks (OPuS-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02303626
First received: November 24, 2014
Last updated: February 15, 2016
Last verified: February 2016
  Purpose
This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.

Condition Intervention Phase
Hereditary Angioedema
HAE
Drug: BCX4161
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: OPuS-2: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX4161 for 12 Weeks as an Oral Prophylaxis Treatment for Attacks of Hereditary Angioedema

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • The mean acute angioedema attack rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Number of attack-free days [ Time Frame: 12 weeks ]
  • Number of subjects who are attack-free [ Time Frame: 12 weeks ]
  • Disease activity, as measured by the 84-day Angioedema Activity Score [ Time Frame: 12 weeks ]
  • Quality of Life, as measured by the Angioedema Quality of Life Questionnaire [ Time Frame: 12 weeks ]
  • Incidence and severity of adverse events and laboratory abnormalities [ Time Frame: 12 weeks ]
  • Quality of Life, as measured by the EuroQoL five-dimensional, 5-level Questionnaire [ Time Frame: 12 weeks ]

Enrollment: 110
Study Start Date: November 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BCX4161 300 mg three times daily
Three BCX4161 capsules (100 mg) and two placebo capsules to be taken three times daily by mouth
Drug: BCX4161 Drug: Placebo
Experimental: BCX4161 500 mg three times daily
Five BCX4161 capsules (100 mg) to be taken three times daily by mouth
Drug: BCX4161
Placebo Comparator: Placebo three times daily
Five placebo capsules to be taken three times daily by mouth
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. A clinical diagnosis of HAE type I or II
  2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, subjects will be required to enter a run-in period to document attacks
  3. Access to acute attack medications
  4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception

Key Exclusion Criteria:

  1. Women who are pregnant or breast-feeding
  2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
  3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks
  4. Current participation in any other investigational drug study or within the last 30 days
  5. History of or current alcohol or drug abuse
  6. Infection with hepatitis B, hepatitis C or HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02303626

  Show 40 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Principal Investigator: Marc Riedl, MD MS UCSD
  More Information

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02303626     History of Changes
Other Study ID Numbers: BCX4161-301
Study First Received: November 24, 2014
Last Updated: February 15, 2016

Keywords provided by BioCryst Pharmaceuticals:
BCX4161
Prophylaxis
Prevention
HAE
Hereditary Angioedema

Additional relevant MeSH terms:
Angioedemas, Hereditary
Angioedema
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on March 22, 2017