Fact CheckerSign in

NCT06238544Active, not recruitingPhase 2

Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Source: ClinicalTrials.gov · Last updated 24 Dec 2025

Brief summary (registry, in English)

This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
132 (actual)
First submitted
22 Jan 2024
Start date
6 Feb 2024
Primary completion date
Dec 2027
Lead sponsor
Chengdu Suncadia Medicine Co., Ltd.
NCT number
NCT06238544

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 132
  • From 6 Feb 2024 to the primary completion date, Dec 2027
  • 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.

Other illness

  • History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)

Other

  • Known or suspected hereditary or acquired complement deficiency;

Who the study is looking for

  • 1\. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
The Blood Disease Hospital of the Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.