Status:
COMPLETED
Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients
Lead Sponsor:
Hangzhou Zede Pharma-Tech Co., Ltd.
Conditions:
Thalassemia
Iron Overload
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.
Detailed Description
1. The study is designed as a single arm and opened phase IIb clinical trial, so as to investigate the safety and efficacy of CN128. 2. A total of 50 eligible subjects are planned to be enrolled, and ...
Eligibility Criteria
Inclusion
- Thalassemia patients.
- The number of blood transfusion per month ≥1. Or hemoglobin can not be maintained at 90g/L above, if blood transfusions is less than once per month.
- Severe iron overloaded patients (serum ferritin\>2500 µg/L or liver iron concentration (LIC)\>15 mg/g dw) despite prior treatment with at least one iron chelator.
- Patients aged 16 and above.
- Volunteer for the trial and sign the informed consent.
Exclusion
- Active hepatitis B (HBsAg positive, HBsAb negative) or hepatitis C (HCV antibody positive, detectable HCV RNA, and Alkaline Phosphatase (ALT) beyond normal range)
- Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers.
- ALT or Aspartate Aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), or serum creatinine \> 1.5 × ULN.
- Neutropenia patient (neutrophil count \< 1.5 × 10\^9 / L).
- Active infection uncontrolled.
- Autoimmune hemolytic anemia patients.
- The patients who are currently taking CYP3A strong inducer or strong inhibitor drugs, or the drug that may extend the QT interval, or the drug that may decrease neutrophil count, but can not temporarily interrupt the use of such drugs.
- Cardiac iron overloaded patients, cardiac magnetic resonance MRI T2\*\<10 ms
- The patients who are allergic or contraindicated to the main ingredients or excipients of CN128 tablets.
- Congenital long QT syndrome or known family history of long QT syndrome, QTc interval\>480 ms, clinically significant ventricular or atrial fast arrhythmia.
- The patients who can not accept MRI as detection means, such as claustrophobic for MRI, pacemaker, and those using ferromagnetic metal implants.
- Birth planner (including male subjects) within or within 3 months after the end of the trial.
- Participated in other clinical trials in the four weeks before taking the test preparation, except for non-interventional studies.
- Pregnant or lactating women.
- Unsuitable to participate in the trial considered by the researchers.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05355766
Start Date
June 13 2022
End Date
March 6 2025
Last Update
March 14 2025
Active Locations (1)
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1
The First Affiliated Hospital Of Guangxi Medical University
Nanning, Guangxi, China