Trials / Completed
CompletedNCT02949128
Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ravulizumab | Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight: ≥ 40 to \< 60 kilograms (kg), 2400 milligrams (mg) loading, then 3000 mg every 8 weeks; ≥ 60 to \< 100 kg, 2700 mg loading, then 3300 mg every 8 weeks; ≥ 100 kg, 3000 mg loading, then 3600 mg every 8 weeks. |
Timeline
- Start date
- 2017-01-11
- Primary completion
- 2023-01-24
- Completion
- 2023-01-24
- First posted
- 2016-10-31
- Last updated
- 2024-02-20
- Results posted
- 2020-02-10
Locations
37 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02949128. Inclusion in this directory is not an endorsement.