NCT07052838CompletedPhase 3
Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia
A Multicenter, Single-Arm, Open-Label Phase III Clinical Study Evaluating the Efficacy and Safety of HSK39297 Tablets in Paroxysmal Nocturnal Hemoglobinuria Patients With Anemia Despite Stable Anti-C5 Antibody Therapy
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 29 Jun 2025
- Start date
- 12 May 2025
- Primary completion date
- 23 Dec 2025
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- NCT number
- NCT07052838
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 36
- From 12 May 2025 to the primary completion date, 23 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active systemic infection within 2 weeks prior to study drug administration.
Other illness
- 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.
Lab values
- Patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x109/L, or platelets \< 30x109/L or neutrophils \< 0.5x109/L).
Other
- Hereditary or acquired complement deficiency.
- Active primary or secondary immunodeficiency.
- Pregnant or Lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.