Chronic Hepatitis B, HBeAg Negative Clinical Trial
Official title:
Termination of Nucleos(t)Ide Analogue Therapy of HBeAg Negative Chronic Hepatitis B - 2nd Register Study
| NCT number | NCT03643172 |
| Other study ID # | 2 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 1, 2018 |
| Est. completion date | July 2024 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Hannover Medical School | Hannover | Lower Saxony |
| Lead Sponsor | Collaborator |
|---|---|
| Hannover Medical School | German Center for Infection Research |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HBsAg | HBsAg Change > 1 log 48 weeks after stopping NA | 48 weeks | |
| Secondary | Virological relapse | HBV DNA > 2,000 IU/ml | at every visit up to 96 weeks | |
| Secondary | Biochemical relapse | ALT > 2 x upper limit of normal | at every visit up to 96 weeks | |
| Secondary | Retreatment | Retreatment until week 48 according to current EASL guidelines | at every visit up to 48 weeks | |
| Secondary | Negativity for HBsAg | HBsAg negative until week 96 of follow-up | at every visit up to 96 weeks | |
| Secondary | timepoint of relapse | timepoint of relapse | at every visit up to 96 weeks | |
| Secondary | T cell response | > 3x change of T cell responses from baseline after in vitro culture with HBV specific peptides | at every visit up to 96 weeks | |
| Secondary | Cytokine response | > 3x change of cytokines from baseline measured by ELISA and Multiplex assay | at every visit up to 96 weeks | |
| Secondary | Chance in HBcrAg | Chance in HBcrAg (U/mL) | at every visit up to 96 weeks | |
| Secondary | Change in HBV RNA | Chance in HBV RNA (U/mL) | at every visit up to 96 weeks |