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OncoMatch/Clinical Trials/NCT06298955

Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

Is NCT06298955 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies OMS906 study drug for paroxysmal nocturnal hemoglobinuria.

Phase 2RecruitingOmeros CorporationNCT06298955Data as of May 2026

Treatment: OMS906 study drugThe 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.

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Extracted eligibility criteria

Prior therapy

Must have received: (OMS906) — prior OMS906 PNH study

Have completed the last dosing visit of the prior OMS906 PNH study.

Lab requirements

Blood counts

platelet count ≥ 30,000/µL, absolute neutrophil count ≥ 500 cells/µL at the start of the Evaluation Period

Liver function

total bilirubin ≤ 2 x ULN, direct bilirubin ≤ 1.5 x ULN, transaminases (ALT/AST) ≤ 2 x ULN unless due to PNH-related hemolysis

Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period. Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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