Trials / Completed
CompletedNCT01192399
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH.
Detailed description
The objective of this study was to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH. In addition, the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in Japanese patients were assessed and compared to that of non-Japanese patients who had participated earlier studies of eculizumab treatment in hemolytic PNH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Eculizumab |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2010-09-01
- Last updated
- 2018-03-13
- Results posted
- 2018-03-13
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01192399. Inclusion in this directory is not an endorsement.