NCT06298955 Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
| NCT ID | NCT06298955 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Omeros Corporation |
| Condition | Paroxysmal Nocturnal Hemoglobinuria |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.
Eligibility Criteria
Inclusion Criteria: 1. Have completed the last dosing visit of the prior OMS906 PNH study. 2. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906. 3. Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug. 4. Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug. 5. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study. 6. Have provided informed consent Exclusion Criteria: 1. Platelet count \<30,000/µL or absolute neutrophil count \<500 cells/µL at the start of the Evaluation Period. 2. Elevation of liver function tests, defined as total bilirubin \> 2 x ULN, direct bilirubin \> 1.5 x