NCT06238544

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
DRUG	HRS-5965 tablets	HRS-5965 tablets until the end of study treatment
DRUG	HRS-5965 Capsules	HRS-5965 capsules.

Timeline

• Start date: 2024-02-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-02-02
• Last updated: 2025-12-24

Locations

2 sites across 1 country: China