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: Recruiting
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
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Fangqiong Li
lifangq@haisco.com
+8602867258840
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2026-01-08
Participants
Target number of participants: 32
Treatments
Experimental: HSK39297
Related Therapeutic Areas
Sponsors
Leads: Haisco Pharmaceutical Group Co., Ltd.