Trials / Completed
CompletedNCT02865720
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
A Phase 3, Open-label, Single-period Study to Evaluate the Safety and Treatment Effect of Intravenous Administration of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CINRYZE 500 U | IV infusion administered twice weekly |
| DRUG | CINRYZE 1000 U | IV infusion administered twice weekly |
Timeline
- Start date
- 2016-09-08
- Primary completion
- 2017-06-23
- Completion
- 2017-06-23
- First posted
- 2016-08-12
- Last updated
- 2021-06-02
- Results posted
- 2018-12-31
Locations
10 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02865720. Inclusion in this directory is not an endorsement.