NCT06593938CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 10 Sept 2024
- Start date
- 25 Oct 2024
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- NCT number
- NCT06593938
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 76
- From 25 Oct 2024 to the primary completion date, 31 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
Other illness
- History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
- Positive of HIV, HBsAg or HCVAb.
Lab values
- Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
Other
- Known or suspected hereditary or acquired complement deficiency;
Who the study is looking for
- Diagnosis of PNH confirmed by flow cytometry with clone size \> 10%.
- Have not received complement inhibitor therapy;
- LDH \> 1.5\*ULN at screening.
- Hemoglobin level \< 10 g/dL at screening.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Blood Disease Hospital of the Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.