Impact of Hepatitis B Immunoglobulins in Patients With Chronic Hepatitis B on Hepatocellular Carcinoma - a Proof of Concept Study

Launched by MEDICAL UNIVERSITY OF GRAZ · Mar 14, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a treatment called hepatitis B immunoglobulin (HBIG) for patients with chronic hepatitis B virus (HBV) who also have liver cancer known as hepatocellular carcinoma (HCC). The researchers want to see if HBIG can help lower the levels of a specific marker (HBsAg) that is linked to a higher risk of liver cancer returning or worsening. By potentially reducing this marker, they hope to stop or slow down the progression of liver cancer while patients are waiting for surgery or a liver transplant.

To participate in this trial, you need to be between 19 and 80 years old and have HCC that is linked to HBV, with surgery planned in at least six weeks or already on the waiting list for a liver transplant. You should be able to understand the study's purpose and give your written consent to join. If you have other serious health issues, are pregnant, or have certain other infections, you may not be eligible. If you join the study, you can expect to receive HBIG treatment before your surgery, and the goal is to see if this treatment can improve your health outcomes while managing your liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 19 years and ≤ 80 of age
• • HBsAg-positive HCC-patients scheduled for resection in ≥6 weeks or HBsAg-positive HCC- patients listed for LT
• • Ability of subjects to understand character and individual consequences of the clinical trial
• • Written informed consent must be available before enrolment in the trial
• Exclusion Criteria:
• • Clinically significant illness (other than HBV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment
• • No eligibility for resection / LT
• • Concurrent any other malignancy
• • Co-infection with hepatitis C virus (defined as HCV RNA positive, HCV RNA-negative/anti-HCV-positive patients can be included) and/or human immunodeficiency virus (HIV)
• • Clinical hepatic decompensation
• • Allergy to HBIG
• • Pregnant, lactating patients