Trials / Completed
CompletedNCT03818607
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABP 959 | intravenous infusion |
| DRUG | Eculizumab | intravenous infusion |
Timeline
- Start date
- 2019-01-22
- Primary completion
- 2022-07-12
- Completion
- 2022-07-12
- First posted
- 2019-01-28
- Last updated
- 2023-05-23
- Results posted
- 2023-05-23
Locations
24 sites across 14 countries: United States, Czechia, Finland, France, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03818607. Inclusion in this directory is not an endorsement.