Actively Recruiting
Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Chronic Hepatitis B Patients
Led by Anhui Medical University · Updated on 2023-06-28
1084
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Anhui Medical University
Lead Sponsor
T
The First Affiliated Hospital, University of Science and Technology of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying chronic hepatitis B (CHB) patients to compare two ways of using pegylated interferon alpha-2b combined with nucleos(t)ide analogs (NAs). The study aims to see which approach—continuous or pulsed therapy—more effectively achieves clinical cure and conversion of hepatitis B surface antigen (HBsAg) and e antigen. This large, multicenter, real-world study will also measure new markers of hepatitis B infection over time to better understand treatment effects. Participants will receive pegylated interferon alpha-2b injections of 180 micrograms subcutaneously once weekly. One group will get continuous treatment for up to 96 weeks, while the other group will follow a pulsed regimen of 8 weeks on treatment followed by 4 weeks off, repeated over 96 weeks. Both groups will continue NA therapy throughout. The study tracks changes in viral markers, including HBV pgRNA, HBcrAg, and anti-HBcAb, at multiple time points during the treatment. During the study, participants will be regularly assessed at baseline and weeks 12, 24, 48, 72, and 96. These assessments include laboratory tests measuring hepatitis B markers to evaluate treatment response, particularly HBsAg and HBsAb conversion rates after 96 weeks. Safety and clinical outcomes will be monitored throughout the study, which is expected to last up to 96 weeks per participant. This study seeks to provide insight into optimizing treatment strategies for CHB patients using interferon combined with NAs.
CONDITIONS
Brief Title
Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, both sexes
- HBsAg positive for more than 6 months
- Continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrollment
- Primary treated patients with surface antigen >1500 IU/ml and meeting treatment guidelines
- Negative urine or serum pregnancy test within 24 hours before first dose (for women of childbearing age)
You will not qualify if you...
- Active hepatitis A, C, D, E and/or HIV infection
- Current or planned use of tibivudine
- Methaemoglobin >100 ng/ml at screening or unstable for 3 months prior
- Liver tumors suggested by imaging
- Decompensated liver disease or related complications
- Pregnant, lactating, or planning pregnancy and unwilling to use contraception
- Low neutrophil or platelet counts and high creatinine
- History of severe psychiatric illness including major depression or psychosis
- History of immune-mediated diseases or elevated autoimmune antibodies
- Severe combined diseases or other malignancies
- History of severe epilepsy or treatment with anti-epileptic drugs
- Unstable control of diabetes, hypertension, thyroid disease, or severe retinopathy
- History of organ transplantation except corneal or hair
- Allergy to interferon or components
- Any condition deemed unsuitable by the investigator
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 96 weeks
Participants receive pegylated interferon alpha-2b injections combined with nucleos(t)ide analogues (NAs) for chronic hepatitis B. Continuous therapy involves weekly injections for up to 96 weeks. Pulsed therapy involves weekly injections for 8 weeks followed by 4 weeks off, repeated up to 96 weeks.
Weekly visits for up to 96 weeks
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 23000
Actively Recruiting
Research Team
Y
Yufeng Gao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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