Clinical trial NCT03643172: Terminator 2 Register
Official title: Termination of Nucleos(t)Ide Analogue Therapy of HBeAg Negative Chronic Hepatitis B - 2nd Register Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B, HBeAg Negative
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: German Center for Infection Research
First posted: 2018-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Non-cirrhotic 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

Brief summary: 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.


Eligibility criteria: 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

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Primary outcomes:
measure: HBsAg
timeFrame: 48 weeks
Secondary outcomes:
measure: Virological relapse
timeFrame: at every visit up to 96 weeks
measure: Biochemical relapse
timeFrame: at every visit up to 96 weeks
measure: Retreatment
timeFrame: at every visit up to 48 weeks
measure: Negativity for HBsAg
timeFrame: at every visit up to 96 weeks
measure: timepoint of relapse
timeFrame: at every visit up to 96 weeks
measure: T cell response
timeFrame: at every visit up to 96 weeks
measure: Cytokine response
timeFrame: at every visit up to 96 weeks
measure: Chance in HBcrAg
timeFrame: at every visit up to 96 weeks
measure: Change in HBV RNA
timeFrame: at every visit up to 96 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
References: