Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Recruiting Phase 3 Interventional Study
Paroxysmal Nocturnal Hemoglobinuria
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Wuhan Createrna Science and Technology Co., Ltd · Industry
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About This Trial

The main purpose of this study is to evaluate the efficacy of MY008211A in PNH patients with residual anemia despite treatment with anti-C5 antibody.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%. 2. Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L.…
Contacts

Wuhan Createrna Science and Technology Co.,Ltd

027-68788900

lcyxzx@createrna.com

CONTACT