Trials / Completed
CompletedNCT06799546
A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy
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
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK39297 tablets | 200mg QD for 24 weeks |
| DRUG | Eculizumab Injection | Eculizumab Injection for 24 weeks |
Timeline
- Start date
- 2025-02-13
- Primary completion
- 2025-11-05
- Completion
- 2025-11-05
- First posted
- 2025-01-29
- Last updated
- 2025-12-22
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06799546. Inclusion in this directory is not an endorsement.