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

Recruiting now · Phase 2

Conditions studied: Paroxysmal Nocturnal Hemoglobinuria

In brief

This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.

Key facts

Study ID

NCT06745622

Run by

Haisco Pharmaceutical Group Co., Ltd.

People needed

47

Starts

2025-01-03

Expected to finish

2027-06-01

Last updated by the study team

2024-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Understand the study procedures and methods, voluntarily participate in this trial.

You may not qualify if…

• Hereditary or acquired complement deficiency;
• Active primary or secondary immunodeficiency;
• History of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants;
• History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis;
• History of serious comorbidities that have been determined to be unsuitable for participation in the study;
• Pregnant or Lactating women.

Where it is running

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.