A Phase III, Multicenter, Randomized, Open Label, Active-Controlled Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Naive to Complement Inhibitor 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 and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.
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 with clone size \> 10% by granulocytes;
• Have not received complement inhibitor treatment;
• Blood LDH values \> 1.5 ×upper limit of the normal range (ULN) ;
• 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
+86-028-67258840
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 66
Treatments
Experimental: HSK39297 tablets
Active_comparator: Eculizumab Injection
Related Therapeutic Areas
Sponsors
Leads: Haisco Pharmaceutical Group Co., Ltd.