Trials / Completed
CompletedNCT01193348
An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eculizumab | Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible. |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2014-01-01
- Completion
- 2014-04-01
- First posted
- 2010-09-01
- Last updated
- 2015-04-29
- Results posted
- 2015-04-29
Locations
17 sites across 9 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT01193348. Inclusion in this directory is not an endorsement.