Trials / Completed
CompletedNCT01095497
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With Hereditary Angioedema (HAE)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CINRYZE | C1 esterase inhibitor (human) |
Timeline
- Start date
- 2010-06-07
- Primary completion
- 2010-12-16
- Completion
- 2010-12-16
- First posted
- 2010-03-30
- Last updated
- 2021-07-09
- Results posted
- 2012-03-08
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01095497. Inclusion in this directory is not an endorsement.