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

NCT06238544 · tracked via the Priya Life Science China tracker

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Phase

Phase 2

Started

2024-02-06

Last updated

2025-12-24

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

HRS-5965 tabletsHRS-5965 Capsules

HRS-5965 tablets: HRS-5965 tablets until the end of study treatment

HRS-5965 Capsules: HRS-5965 capsules.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.)

Primary outcome measure(s)

Incidence and severity of adverse events. — Every six months,for about 3 years

Trial sites (2)

Facility	City	Region	Status
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing Municipality
The Blood Disease Hospital of the Chinese Academy of Medical Sciences	Tianjin	Tianjin Municipality

More Chengdu Suncadia Medicine Co., Ltd. trials in China

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A Clinical Study of HRS-8797 in Healthy Participants Starting soon

A Clinical Study of HRS-5765 in Healthy Participants Recruiting

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Other trials for the same condition

A Study of the Efficacy and Safety of FXS6837 Capsules Compared to Eculizumab for 24 Weeks in Patients With PNH. Starting soon

A Multicenter, Open-label Study Evaluating the Long-term Safety and Efficacy of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria Enrolling by invitation

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment Active, not recruiting

A Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients Active, not recruiting

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06238544 on ClinicalTrials.gov ↗ ← All trials in China