Trials / Completed
CompletedNCT06593938
A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
A Multicenter, Randomized, Open-label, Active-comparator Controlled Phase III Study to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Patients With Paroxysmal Nocturnal Hemoglobinuria
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS-5965 capsule | HRS-5965 capsule for 24 weeks |
| DRUG | Eculizumab Injection | Eculizumab Injection for 24 weeks |
Timeline
- Start date
- 2024-10-25
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
- First posted
- 2024-09-19
- Last updated
- 2025-09-11
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06593938. Inclusion in this directory is not an endorsement.