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NCT Number: NCT06745622

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

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.

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Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

He

CONTACT

[email protected]

+8615312052798

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HSK39297 tablets

Drug

HSK39297 tablets until the end of treatment

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

  5. Proportion of participants with Major Adverse Vascular Events (MAVEs)

    Time frame: through study completion，about 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Li

CONTACT

[email protected]

+8602867258840

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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