Terminator 2 Register

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Chronic Hepatitis B, HBeAg Negative

Study type: Observational

Funder types: Other

Identifiers

NCT03643172

2

Details and patient eligibility

About

All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg.
2. Age > 18 years
3. Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)
4. At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml)
5. HBeAg negative
6. Willingness to give written informed consent and willingness to participate and to comply with the protocol.

Exclusion criteria

1. HIV infection, persistent HDV-infection, persistent HCV infection

2. History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).

3. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

4. Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)

5. Patients with hepatocellular carcinoma

6. History of major organ transplantation or other immunosuppressive conditions

7. History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

8. History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study