Status:
COMPLETED
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and...
Detailed Description
Study Design: This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE. Medical screening (...
Eligibility Criteria
Inclusion
- Patients fulfilling the following criteria at Screening are eligible for participation in the study:
- Age 13 years or older
- Laboratory confirmed diagnosis of HAE
- A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months).
- Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception.
- Provided written informed consent (and written assent for minors)
- Willingness and ability to comply with all protocol procedures
Exclusion
- Patients who meet any of the following criteria at Screening are to be excluded from study participation:
- Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
- Diagnosis of acquired angioedema (AAE)
- Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant
- Treatment with any investigational drug in the past 30 days
- Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
- Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02247739
Start Date
December 1 2014
End Date
September 1 2016
Last Update
December 8 2017
Active Locations (10)
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1
University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
2
University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
3
Washington University Division of Allergy and Immunology
St Louis, Missouri, United States, 63141
4
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States, 97035