Actively Recruiting
A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-12-20
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety, tolerability, and effectiveness of HSK39297 in adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have previously completed treatment with HSK39297. The study is multicenter and open-label, focusing on understanding how patients respond to continued treatment over an extended period. The sponsor leading this study is Haisco Pharmaceutical Group Co., Ltd. Participants will continue taking HSK39297 tablets until the end of the study treatment period. There are no placebo or comparator groups, as all eligible participants are those who have already received the study drug. The treatment will be maintained throughout the study to monitor long-term effects. Throughout the study, patients will be monitored for adverse events to assess safety and tolerability over about two years. Researchers will also measure hemoglobin levels, the need for red blood cell transfusions, rates of breakthrough hemolysis, and incidence of major adverse vascular events. Participants will be followed closely to evaluate these outcomes and ensure ongoing safety.
CONDITIONS
Brief Title
Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have previously received and completed HSK39297 treatment
- Researchers judge that benefits of continuing HSK39297 outweigh risks and may help the patient
- Understand the study procedures and agree to participate voluntarily
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 caused by encapsulated organisms or Mycobacterium tuberculosis
- Serious comorbidities that make participation unsuitable
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 2 years
Participants receive HSK39297 tablets until the end of treatment.
Regular visits during treatment as per study schedule
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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