A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With P
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
| Condition(s) | PNH - Paroxysmal Nocturnal Hemoglobinuria |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 any complement inhibitor therayp; * LDH \> 1.5×ULN detected two times during the screening period (interval of 2 to 8 weeks); * Hb meets one of the following conditions: (1) Hb \<100 g/L at the first screening visit, and subjects receive RBC transfusion because of PNH-related anemia during the screening period; (2) The average Hb of two tests during the screening period \<100 g/L (interval of 2\~8 weeks); * Vaccination against Neisseria meningitidis and Streptococcus pneumoniae before the first adm |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | S-INFINITY Pharmaceuticals Co., Ltd |
| Locations | Tianjin, China |
| Start date | 2025-04-30 |
| NCT ID | NCT06978699 |
| Official listing | https://clinicaltrials.gov/study/NCT06978699 |