ClinicalTrials.gov record NCT06745622
Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria
A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This open-label Phase 2 study follows adults with paroxysmal nocturnal hemoglobinuria (PNH) who previously completed HSK39297 treatment. Participants continue HSK39297 tablets and are followed for about two years. The study collects safety information and blood-related outcome data.
What it is studying. The study is testing the long-term safety, tolerability, and efficacy of HSK39297 in people with PNH who completed prior HSK39297 treatment. It tracks adverse events, hemoglobin levels, transfusion needs, breakthrough hemolysis, and major adverse vascular events.
What the researchers hope to learn. To evaluate long-term safety and tolerability of HSK39297 and to collect efficacy data including hemoglobin change, transfusion independence, rate of breakthrough hemolysis, and major adverse vascular events.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- HSK39297 tablets
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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;
- Understand the study procedures and methods, voluntarily participate in this trial.
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;
- History of serious comorbidities that have been determined to be unsuitable for participation in the study;
- Pregnant or Lactating women.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will continue taking HSK39297 tablets for the duration of the study (eligible participants may remain on treatment until study end; outcomes are followed through about 2 years). They will attend regular clinic visits for safety monitoring, report any side effects, and have blood tests to check hemoglobin levels and transfusion needs. Study staff will record adverse events, episodes of breakthrough hemolysis, transfusion status, and any major adverse vascular events.
How the study is structured. Interventional Phase 2, single-group, open-label trial. All enrolled participants receive HSK39297 tablets with no blinding or placebo; participants are followed and assessed over the study period (about 2 years).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on paroxysmal nocturnal hemoglobinuria
Important dates
- Study start
- Jan 3, 2025 (estimated)
- Primary completion
- June 2027 (estimated)
- Study completion
- June 2027 (estimated)
- Target enrollment
- 47 participants (estimated)
- Last updated on registry
- Dec 20, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Li 📞 +8602867258840 ✉ lifangq@haisco.com
Participating sites (1)
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Nanjing, Jiangsu · China
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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