Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called HSK39297 to see how safe it is and how well it works for people with a condition called Paroxysmal Nocturnal Hemoglobinuria (PNH). The study is open to adult patients who have already completed a previous study with HSK39297 and are considered to benefit from continuing the treatment. If you are between the ages of 65 and 74 and have PNH, you might be eligible to participate in this long-term study.

Participants will be able to keep taking HSK39297 for as long as the study lasts, as long as they meet the eligibility criteria. However, certain conditions could prevent someone from joining, such as having a history of certain infections, undergoing specific surgeries, or if they are pregnant or breastfeeding. Throughout the trial, participants will be closely monitored to ensure their safety and to gather important information about how the medication is working for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients With PNH who have previously received and completed HSK39297 treatment , and According to the researchers' judgment, the benefits of treatment outweigh the risks and may benefit from continued treatment with HSK39297;
• • 2. Understand the study procedures and methods, voluntarily participate in this trial.
• Exclusion Criteria:
• • 1. Hereditary or acquired complement deficiency;
• • 2. Active primary or secondary immunodeficiency;
• • 3. History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
• • 4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
• • 5. History of serious comorbidities that have been determined to be unsuitable for participation in the study;
• • 6. Pregnant or Lactating women.