Long-term safety and tolerability of HSK39297 for patients with PNH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Li
• Email: lifangq@haisco.com
• Phone: +8602867258840

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral HS-10542 for paroxysmal nocturnal hemoglobinuria

  This study will test whether the oral drug HS-10542 can reduce hemolysis and raise hemoglobin in adults with PNH, including those not fully helped by C5 inhibitor therapy.

  Recruiting Phase 1/2 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Hangzhou, Zhejiang · NCT07470762

• Danicopan added to ravulizumab or eculizumab for PNH in Korea

  This will see if adding Danicopan to ravulizumab or eculizumab is safe and helps people with PNH who are treated in routine care in Korea.

  Recruiting at 3 sites AstraZeneca · Busan and 3 other locations · NCT07457151

• Iptacopan use in Korean patients with PNH or C3G

  This post-marketing surveillance study tests how well iptacopan works and how safe it is for Korean adults with PNH or C3G in real-world care.

  Recruiting at 3 sites Novartis · Jeollanam and 2 other locations · NCT07416162

• Pozelimab + cemdisiran for adults with PNH whose current treatment isn't working

  This trial tests whether combining pozelimab and cemdisiran can better reduce hemolysis in adults with PNH whose C5 inhibitor treatment isn’t controlling their disease.

  Recruiting at 20 sites Phase 3 Regeneron Pharmaceuticals · Ribeirão Preto, São Paulo and 19 other locations · NCT07154745

• Evaluating MY008211A for treating anemia in PNH patients on anti-C5 therapy

  This study is testing a new treatment called MY008211A to see if it can help people with PNH who still have anemia even while on anti-C5 therapy.

  Recruiting Phase 3 Wuhan Createrna Science and Technology Co., Ltd · Beijing, Beijing Municipality · NCT06932471

• Iptacopan treatment for adults with PNH in China

  This study will try iptacopan (LNP023) in adults with PNH in China to see if it improves clinical and laboratory outcomes and changes healthcare use.

  Recruiting at 14 sites Novartis · Hefei, Anhui and 13 other locations · NCT06931691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.