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

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238544
• Other study ID #: HRS-5965-203
• Status: Recruiting
• Phase: Phase 2
• Start date: February 6, 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Chengdu Suncadia Medicine Co., Ltd.
• Contact: Sheng Qi
• Phone: 0518-82342973
• Email: sheng.qi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 until the end of treatment in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;

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

Related Conditions & MeSH terms

• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Paroxysmal Nocturnal Hemoglobinuria

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Blood Disease Hospital of the Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events.		Every six months,for about 3 years
Secondary	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..		Every six months ,for about 3 years
Secondary	Proportion of participants who remain free from transfusions was assessed every half a year during treatment..		Every six months,for about 3 years
Secondary	Rate of breakthrough hemolysis was assessed every half a year during treatment		Every six months,for about 3 years
Secondary	Proportion of participants with Major Adverse Vascular Events MAVEs.		Every six months,for about 3 years
Secondary	Plasma concentration of HRS-5965.		Start of Treatment to end of study,for about 3 years