Phase 2 Safety and Efficacy Study of RA101495 to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | April 17, 2017 |
| End Date: | March 28, 2018 |
A Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to Eculizumab
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab.
Patients will be treated with RA101495 for 12 weeks.
Paroxysmal Nocturnal Hemoglobinuria (PNH) who have an inadequate response to eculizumab.
Patients will be treated with RA101495 for 12 weeks.
Inclusion Criteria:
- Diagnosis of PNH by flow cytometry
- Inadequate response to eculizumab defined as having received eculizumab for at least 6
months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the
presence of a known C5 mutation conferring resistance to eculizumab
Exclusion Criteria:
- History of meningococcal disease
- Current systemic infection or suspicion of active bacterial infection
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