Actively Recruiting
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
Led by Xiangya Hospital of Central South University · Updated on 2024-12-24
400
Participants Needed
4
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.
CONDITIONS
Official Title
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years inclusive, any gender
- Positive hepatitis B surface antigen (HBsAg) for at least 6 months
- Family history of liver cancer in first-degree or second-degree relatives
- Planning to start or currently receiving Peginterferon alpha-2b combined with nucleoside (acid) analogs or nucleoside (acid) analogs alone
- Negative urine or serum pregnancy test within 24 hours before first dose (for women of childbearing age)
- Willing to receive treatment and able to sign informed consent
You will not qualify if you...
- Allergy to interferon
- Previous antiviral treatment with telbivudine
- Alanine Aminotransferase (ALT) level greater than 10 times the upper limit of normal
- Total bilirubin greater than 2 times the upper limit of normal
- Decompensated liver cirrhosis
- Neutrophil count less than 1.5 x 10^9/L or platelet count less than 80 x 10^9/L
- Severe lesions in vital organs such as heart, lungs, kidneys, brain, or eyes
- Autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction
- Confirmed or suspected liver cancer or other cancers
- History of organ transplant or preparing for transplantation
- Current use of immunosuppressants
- Pregnant or planning pregnancy within 2 years
- Alcohol or drug addiction
- HIV co-infection
- Any other condition making interferon use unsuitable as judged by the doctor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
2
Chenzhou Second People's Hospital
Chenzhou, Hunan, China
Actively Recruiting
3
First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
Actively Recruiting
4
Hengyang Third People's Hospital
Hengyang, Hunan, China
Actively Recruiting
Research Team
L
LeDu Zhou, Ph.D
CONTACT
L
Lei Fu, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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