Long-term safety and tolerability of HSK39297 for patients with PNH
A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）
This study is testing if continuing treatment with HSK39297 is safe and effective for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have already used this medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06745622 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study evaluates the long-term safety, tolerability, and efficacy of HSK39297 in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have previously completed treatment with HSK39297. Eligible participants can continue receiving HSK39297 until the end of the study, allowing researchers to gather extensive data on its long-term effects. The study aims to determine whether the benefits of continued treatment outweigh any associated risks.
Who should consider this trial
Good fit: Ideal candidates are adult patients with PNH who have previously completed treatment with HSK39297.
Not a fit: Patients with hereditary or acquired complement deficiencies or serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective long-term treatment option for patients with PNH.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in assessing long-term treatment effects in chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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; 2. Understand the study procedures and methods, voluntarily participate in this trial. 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 organ transplants; 4. History of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or Mycobacterium tuberculosis; 5. History of serious comorbidities that have been determined to be unsuitable for participation in the study; 6. Pregnant or Lactating women.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Li
- Email: lifangq@haisco.com
- Phone: +8602867258840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.