A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Recruiting
Phase 2
Interventional Study
PNH - 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 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- S-INFINITY Pharmaceuticals Co., Ltd · Industry
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About This Trial
This is a multicenter, randomized, single-blind Phase II trial to evaluate the efficacy and safety of XH-S003 capsules in PNH patients. About 24 PNH patients will be enrolled and randomized to three dose levels and take XH-S003 capsules orally
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female with aged ≥18 years old;
* Weight ≥40 kg and BMI≥18 kg/m2 ;
* Diagnosed with PNH: with red blood cell or granulocyte clone levels \>10% detected by flow cytopy within 6 months prior to screening or during screening;
* Patients who have not previously received an…
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