A Multicenter, Single-Arm, Open-Label Phase III Clinical Study Evaluating the Efficacy and Safety of HSK39297 Tablets in Paroxysmal Nocturnal Hemoglobinuria Patients With Anemia Despite Stable Anti-C5 Antibody Therapy
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age ≥ 18 and ≤ 75 years, Male and female patients.
• Diagnosis of PNH based on flow cytometry showing \>10% granulocyte clone size during the screening period.
• Stable use of Anti-C5 antibody at least 6 months prior to enrollment.
• Hemoglobin level \< 10 g/dL at screening.
Locations
Other Locations
China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Time Frame
Start Date: 2025-05-12
Completion Date: 2026-01-05
Participants
Target number of participants: 36
Treatments
Experimental: HSK39297
Related Therapeutic Areas
Sponsors
Leads: Haisco Pharmaceutical Group Co., Ltd.