Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Recruiting
Phase 1
Phase 2
Interventional Study
Paroxysmal Nocturnal Hemoglobinuria
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
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About This Trial
This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.
2. It was confirmed to be PNH during screening, and the clone size of red blood cells or/and granulocytes or/and monocytes was detected by flow cytopy ≥10%
3. Stable use of C5 complement inhibit…
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