OncoMatch/Clinical Trials/NCT07256301
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Is NCT07256301 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies EA5 for pnh - paroxysmal nocturnal hemoglobinuria.
Treatment: EA5 — This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: complement inhibitor
Exception: allowed if discontinued for ≥5 half-lives prior to screening
Previously treated with a complement inhibitor, which has been discontinued for ≥5 half-lives prior to screening
Lab requirements
Blood counts
Platelet count ≥30 × 10^9/L (without transfusion support within 7 days), ANC ≥0.5 × 10^9/L (without short-acting G-CSF within 14 days or long-acting G-CSF within 28 days)
Kidney function
serum creatinine ≤2.5 × ULN and estimated creatinine clearance ≥30 mL/min (Cockcroft-Gault)
Liver function
ALT ≤3 × ULN, OR both direct bilirubin and ALP ≤2 × ULN at screening
Platelet count ≥30 × 10^9/L at screening (without transfusion support within 7 days), and absolute neutrophil count (ANC) ≥0.5 × 10^9/L (without short-acting granulocyte colony-stimulating factor (G-CSF) within 14 days or long-acting G-CSF within 28 days). Adequate liver function, defined as alanine aminotransferase (ALT) ≤3 × ULN, OR both direct bilirubin and alkaline phosphatase (ALP) ≤2 × ULN at screening. Adequate renal function, defined as serum creatinine ≤2.5 × ULN and an estimated creatinine clearance ≥30 mL/min as calculated by the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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