A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Last updated: February 24, 2025
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hemoglobinuria, Paroxysmal

Bone Marrow Disorder

Anemia

Treatment

HRS-5965 capsule

Eculizumab Injection

Clinical Study ID

NCT06593938
HRS-5965-301
  • Ages > 18
  • All Genders

Study Summary

A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of PNH confirmed by flow cytometry with clone size > 10%.

  2. Have not received complement inhibitor therapy;

  3. LDH > 1.5*ULN at screening.

  4. Hemoglobin level < 10 g/dL at screening.

Exclusion

Exclusion Criteria:

  1. Known or suspected hereditary or acquired complement deficiency;

  2. Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L;platelets <30x109/L; neutrophils <0.5x109/L);

  3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose ofHRS-5965;

  4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus,etc.)

  5. Positive of HIV, HBsAg or HCVAb.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: HRS-5965 capsule
Phase: 3
Study Start date:
October 25, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100730
    China

    Site Not Available

  • The Blood Disease Hospital of the Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Site Not Available

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