Trials / Completed
CompletedNCT01194804
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eculizumab | Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days. |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2010-09-01
- Completion
- 2011-03-01
- First posted
- 2010-09-03
- Last updated
- 2019-09-17
- Results posted
- 2019-07-12
Source: ClinicalTrials.gov record NCT01194804. Inclusion in this directory is not an endorsement.