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.
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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…
Contacts

Rong Fu

+86-13920350233

furong8369@tmu.edu.cn

CONTACT

Hui Liu

+86-13821113189

liuhui8003@qq.com

CONTACT