Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Recruiting
Phase 3
Interventional Study
Paroxysmal Nocturnal Haemoglobinuria (PNH)
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.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 66 (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 compared to eculizumab in PNH patients.
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. Mean hemoglobin level \<100 g/L at screening.
3. LDH \> 1.5 x Upper Limit of Normal (ULN) at screening.
4. Vaccin…
Contacts