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

Launched by CHENGDU SUNCADIA MEDICINE CO., LTD. · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and tolerability of a medication called HRS-5965 in patients who have a condition known as Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is a rare blood disorder that can cause symptoms like fatigue and dark-colored urine. In this study, participants who have previously taken HRS-5965 and experienced benefits will continue to receive the medication in tablet form. The goal is to see how well they tolerate the treatment over a longer period.

To be eligible for this trial, patients need to be between the ages of 65 and 74 and must have previously completed treatment with HRS-5965, showing that it helped them. However, individuals with certain conditions, like specific types of infections or problems with their immune system, cannot participate. If you join the trial, you can expect regular check-ups to monitor your health and how well you respond to the medication. This trial is currently recruiting participants, so it's an opportunity for those who may benefit from ongoing treatment.

Gender

ALL

Eligibility criteria

• 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.)