Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Medical University of Graz

Conditions:

Hepatocellular Carcinoma

HBV

Eligibility:

All Genders

19-80 years

Phase:

NA

Brief Summary

In the current literature, infection with the hepatitis B virus (HBV) is described as one of the main risk factors for the development of hepatocellular carcinoma (HCC). According to the current stud...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT05293158

Start Date

November 1 2024

End Date

June 1 2026

Last Update

January 18 2024

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