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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HSK39297 tablets

Treatment groups

47 Participants
are divided into 1 treatment group