Trials / Completed
CompletedNCT02584959
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | C1 esterase inhibitor [human] liquid | C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
- First posted
- 2015-10-23
- Last updated
- 2021-06-08
- Results posted
- 2018-11-28
Locations
27 sites across 7 countries: United States, Canada, Germany, Hungary, Israel, Romania, Spain
Source: ClinicalTrials.gov record NCT02584959. Inclusion in this directory is not an endorsement.