Actively Recruiting
Study of Long-term Safety, Tolerability, and Efficacy of HSK39297 Tablets in Adults with Paroxysmal Nocturnal Hemoglobinuria An Open-label Multicenter Clinical Trial
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-12-20
47
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, open-label Phase 2 study to evaluate the long-term safety, tolerability, and effectiveness of HSK39297 in adults with Paroxysmal Nocturnal Hemoglobinuria (PNH). The study includes patients who have previously received and completed treatment with HSK39297. The goal is to understand how patients respond to continued treatment over an extended period. Participants will continue taking HSK39297 tablets for the duration of the study, allowing researchers to monitor ongoing treatment effects. This open-label design means both the participants and researchers know the treatment being given. The study focuses on maintaining HSK39297 treatment until the study ends. Throughout the study, which lasts about two years, participants will be regularly monitored for any side effects or adverse events and their severity. Researchers will assess patients' overall safety and how well they tolerate the treatment. The study will also gather data to evaluate the ongoing benefits and risks of HSK39297 in managing PNH.
CONDITIONS
Official Title
Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with PNH who have previously received and completed HSK39297 treatment and are judged by researchers to benefit from continued treatment
- Understand the study procedures and voluntarily agree to participate
You will not qualify if you...
- 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 from encapsulated organisms or Mycobacterium tuberculosis
- History of serious comorbidities unsuitable for study participation
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
L
Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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