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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HSK39297 tablets

    Drug

    HSK39297 tablets until the end of treatment

Treatment groups

47 Participants
are divided into 1 treatment group
Group A: HSK39297Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events

Time frame
through study completion,about 2 years

Secondary outcomes

1

Proportion of participants achieving hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions

Time frame
through study completion,about 2 years
2

Change From Baseline in Hemoglobin in the absence of red blood cell transfusions

Time frame
through study completion,about 2 years
3

Proportion of participants who remain free from transfusions

Time frame
through study completion,about 2 years
4

Rate of breakthrough hemolysis (BTH)

Time frame
through study completion,about 2 years

Other outcomes

Sponsors and contacts

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