Evaluating Peginterferon to Reduce Liver Cancer Risk in Chronic Hepatitis B Patients

A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks

This study is testing if a medication called peginterferon can help reduce the risk of liver cancer in people with chronic hepatitis B who are at higher risk for the disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 267 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 9 sites (Chengdu and 8 other locations)
• Trial ID: NCT05671315 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of peginterferon alfa-2b in reducing the incidence of hepatocellular carcinoma (HCC) among patients with chronic hepatitis B (CHB) who are at intermediate to high risk for liver cancer. The study will involve a multicenter, randomized, open-label, controlled design, comparing peginterferon treatment to standard nucleos(t)ide analogue therapy. Participants will be monitored for changes in liver cancer incidence over time, with a focus on those who have been on nucleos(t)ide analogue treatment for at least 24 weeks. The trial seeks to provide prospective data on the potential benefits of peginterferon in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with chronic hepatitis B and intermediate to high risk for liver cancer.

Not a fit: Patients with low risk for liver cancer or those who have not received nucleos(t)ide analogue treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of hepatocellular carcinoma in patients with chronic hepatitis B.

How similar studies have performed: Previous retrospective studies have indicated that peginterferon may reduce liver cancer risk, but this approach is still being evaluated in prospective trials.

Eligibility criteria

Inclusion Criteria:

* Aged 18 to 60 years and no gender limit (including 18 and 60 years).
* HBsAg positive for more than 6 months.
* Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met.

  * Male patient aged above 40 years.
  * Patients with a history of cirrhosis and/or family history of liver cancer.
  * Patients with metabolic diseases, such as diabetes, fatty liver, etc.
  * Any liver cancer assessment model of chronic hepatitis B patients suggested that liver cancer was at intermediate to high risk.
* Have received Nucleos(t)ide analogue treatment for more than 24 weeks, and currently receiving Nucleos(t)ide analogue, while HBV DNA is undetectable (HBV DNA below 300 IU/mL or 1000 copies/mL).
* Urine and/or serum pregnancy test within 24 hours prior to the first dose must be negative for female patients of childbearing potential.
* Understand and voluntarily sign informed consent form.

Exclusion Criteria:

* Patients co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
* Patients who have previously received interferon therapy.
* Alpha-fetoprotein greater than 100 ng/mL at screening, or liver imaging suggestive of liver tumor.
* Decompensated liver disease (Child-Pugh score ≥ 5).
* Pregnant or lactating women or patients planning to become pregnant or cannot to take contraception during the study.
* Neutrophil count \< 1.5 x 109/L, platelet count \< 90 x 109 cells/L, or Creatinine 1.5 times higher than the upper limit of normal.
* Patients with severe psychiatric history, particularly depression.
* History of immune-mediated disease or levels of autoimmune antibodies markedly elevated.
* Patients with severe diseases in major organ, such as heart, lung, kidney, brain, blood, etc., and patients with malignancies.
* Patients with poorly controlled diabetes, hypertension, and thyroid disease.
* Patients with history of severe retinopathy or other evidence of retinopathy.
* Patient who ever received organ transplantation, or planning to receive organ transplantation.
* Patients who are allergic to interferon or any of its ingredients.
* Other circumstances that the investigator deems inappropriate to participate in this study.

Where this trial is running

Chengdu and 8 other locations

• The Public Health Clinical Center Of Chengdu — Chengdu, China (Recruiting)
• The First Affiliated Hospital of USTC Anhui Provincial Hospital — Hefei, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
• Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• Tongren Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• The Fifth People's Hospital Of Suzhou — Suzhou, China (Recruiting)
• Xiamen Hospital of Traditional Chinese Medicin — Xiamen, China (Recruiting)
• The Tirth Affiliated Hospital Of Xinxiang Medical University — Xinxiang, China (Recruiting)

Study contacts

• Principal investigator: Qing Xie — Ruijin Hospital, Shanghai
• Study coordinator: Qing Xie, Ph.D

Conditions Chronic Hepatitis B; Intermediate to High Risk of HCC; Hepatocellular Carcinoma; Peginterferon; Nucleoside analogue