A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria(PNH)

Last updated: August 16, 2024
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Hemoglobinuria, Paroxysmal

Anemia

Proteinuria

Treatment

HSK39297

Clinical Study ID

NCT06561841
HSK39297-201
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, randomized, open-label phase 2 study. Adult Patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HSK39297 for 24 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female participants ≥ 18 years of age;

  2. Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes;

  3. Have not received complement inhibitor treatment;

  4. Blood lactate dehydrogenase(LDH) values > 1.5 ×upper limit of the normal range (ULN) ;

  5. Hemoglobin level < 100 g/L during the screening period.

Exclusion

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 organtransplants;

  4. History of recurrent invasive infections caused by encapsulated organisms( e.g.meningococcus or pneumococcus) or Mycobacterium tuberculosis;

  5. Patients with laboratory evidence of bone marrow failure (reticulocytes < 100x10^9/L, or platelets < 30x10^9/L or neutrophils < 0.5x10^9/L) ;

  6. Active systemic infection within 2 weeks prior to study drug administration;

  7. History of serious comorbidities that have been determined to be unsuitable forparticipation in the study.

  8. Pregnant or Lactating women.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: HSK39297
Phase: 2
Study Start date:
July 17, 2024
Estimated Completion Date:
March 13, 2025

Connect with a study center

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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