Trials / Completed
CompletedNCT00851409
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Pharming Technologies B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human C1 Inhibitor | 50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period. |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2010-03-01
- Completion
- 2010-04-01
- First posted
- 2009-02-26
- Last updated
- 2018-06-26
- Results posted
- 2013-01-31
Locations
2 sites across 2 countries: Netherlands, Romania
Source: ClinicalTrials.gov record NCT00851409. Inclusion in this directory is not an endorsement.