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NCT06746701Recruiting

Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.

Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
10 Dec 2024
Start date
25 May 2023
Primary completion date
25 May 2027
Lead sponsor
Xiangya Hospital of Central South University
NCT number
NCT06746701

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 25 May 2023 to the primary completion date, 25 May 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Post-organ transplant or preparing for organ transplantation;
  • Currently using immunosuppressants;
  • Alcohol or drug addicts;

Other illness

  • Allergy to interferon;
  • History of using telbivudine for antiviral treatment;
  • Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);
  • Confirmed or suspected liver cancer or other malignant tumors;
  • HIV co-infection;
  • Other conditions deemed unsuitable for interferon use by the attending physician.

Lab values

  • ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
  • Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 80 x 10\^9/L;

Other

  • Decompensated liver cirrhosis;
  • Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;
  • Pregnant or planning to become pregnant within 2 years;

Who the study is looking for

  • Age18-65 years (inclusive of 18 and 65), no restriction on gender;
  • HBsAg positive history for at least 6 months;
  • Family history of liver cancer \[including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer\];
  • Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
  • Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
  • Willing to receive treatment and sign an informed consent form.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chenzhou Second People's Hospital
Coordinator of this site? Confirm its status
ChenzhouChinaRecruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Hengyang Third People's Hospital
Coordinator of this site? Confirm its status
HengyangChinaRecruiting
First Affiliated Hospital of Nanhua University
Coordinator of this site? Confirm its status
HengyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.