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CompletedNCT07052838Updated Feb 11, 2026

Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia

A Phase 3 interventional study of HSK39297 tablets in Paroxysmal Nocturnal Haemoglobinuria (PNH), sponsored by Haisco Pharmaceutical Group Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.

02

Conditions studied

  • Paroxysmal Nocturnal Haemoglobinuria (PNH)

Keywords

  • Paroxysmal Nocturnal Hemoglobinuria
03

In context

Hemoglobinuria, Paroxysmal

188 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 48 are open to participants now.

This study's enrollment of 36 is close to the median of 34 across 147 interventional studies indexed under Hemoglobinuria, Paroxysmal.

Browse Hemoglobinuria, Paroxysmal studies →

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years, Male and female patients.
  • Diagnosis of PNH based on flow cytometry showing >10% granulocyte clone size during the screening period.
  • Stable use of Anti-C5 antibody at least 6 months prior to enrollment.
  • Hemoglobin level \< 10 g/dL at screening.

Exclusion criteria

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.
  • Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x109/L, or platelets \< 30x109/L or neutrophils \< 0.5x109/L).
  • Active systemic infection within 2 weeks prior to study drug administration.
  • History of serious comorbidities that have been determined to be unsuitable for participation in the study.
  • Pregnant or Lactating women.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    HSK39297

    Drug: HSK39297 tablets

Interventions

  • DrugHSK39297 tablets

    200mg QD

06

What researchers measure

Primary outcomes

  1. Proportion of participants achieving hemoglobin levels ≥ 120 g/L at least on three out of four measurements in the absence of red blood cell transfusions

    Time frame: 18 to 24 weeks

Secondary outcomes

  1. Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L at least on three out of four measurements in the absence of red blood cell transfusions

    Time frame: 18 to 24 weeks

  2. Percentage of patients who did not receive a blood transfusion.

    Time frame: 18 to 24 weeks

  3. Change from baseline in hemoglobin

    Time frame: Baseline, week 18 to 24

  4. Change From Baseline in Reticulocyte Count

    Time frame: Baseline, week 18 to 24

  5. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue score

    The FACIT-F is a 13-item questionnaire with a 0-52 range. A higher total score indicates less fatigue and better function.

    Time frame: Baseline, week 18 to 24

  6. Percent change from baseline in lactate dehydrogenase (LDH)

    Time frame: Baseline, week 18 to 24

  7. Rate of breakthrough hemolysis (BTH)

    Time frame: 24 weeks

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

    Time frame: 24 weeks

07

Study locations

2 sites
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07052838
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jul 7, 2025
Start date
May 12, 2025
Primary completion
Dec 23, 2025
Completion
Jan 5, 2026
Last update
Feb 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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