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

December 18, 2025 updated by: Chengdu Suncadia Medicine Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • The Blood Disease Hospital of the Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Known or suspected hereditary or acquired complement deficiency;
  2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-5965 Group
Drug: HRS-5965 tablets
HRS-5965 tablets until the end of study treatment
Drug: HRS-5965 Capsules
HRS-5965 capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events.
Time Frame: Every six months,for about 3 years
Every six months,for about 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions was assessed every half a year during treatment..
Time Frame: Every six months ,for about 3 years
Every six months ,for about 3 years
Proportion of participants who remain free from transfusions was assessed every half a year during treatment..
Time Frame: Every six months,for about 3 years
Every six months,for about 3 years
Rate of breakthrough hemolysis was assessed every half a year during treatment
Time Frame: Every six months,for about 3 years
Every six months,for about 3 years
Proportion of participants with Major Adverse Vascular Events MAVEs.
Time Frame: Every six months,for about 3 years
Every six months,for about 3 years
Plasma concentration of HRS-5965.
Time Frame: Start of Treatment to end of study，for about 3 years
Start of Treatment to end of study，for about 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-5965-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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