NCT06051357CompletedPhase 2
Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
An Multicenter, Randomized, Open-label Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 25 Mar 2024
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- NCT number
- NCT06051357
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 26
- From 15 Nov 2023 to the primary completion date, 25 Mar 2024
- 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;
- Hemoglobin level \< 10 g/dL.
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.