Overview

Roll-over After 3-year Trial for Tenofovir in Mild Chronic Hepatitis B

Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
0
Participant gender:
All
Summary
This open-label study is an roll-over extension of a randomized trial "Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight Aminotransferase Elevation" (NCT01522625). After finishing the 3-year therapeutic trial, all patients receive open-label TDF for another 3 years. All patients undergo liver biopsy to evaluate the stage of fibrosis after the 3-year open-label therapy. During the 3-year period, patients were followed up every 12 weeks for the biochemical, serological, virological parameters, and adverse reactions. The primary outcome is the progression of liver fibrosis. Safety issues such as change of renal function and bone mineral density are 2nd outcomes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
E-DA Hospital
Collaborator:
Taipei Institute of Pathology
Treatments:
Tenofovir
Criteria
Inclusion Criteria:

- all participants should have finished the clinical trial Disoproxil Fumarate in Chronic Hepatitis B Patients with High Viral Load but Slight
Aminotransferase Elevation> without drop-out.

- willingness to adhere to treatment and follow-up plans

Exclusion Criteria:

- co-infection with HIV, HCV, or HDV

- presence of cirrhosis on histopathology

- hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin
time > 3 seconds

- concurrent malignant diseases including hepatocellular carcinoma

- severe co-morbidity with life expectancy < 1year

- pregnant or lactating women

- organ transplantation except cornea or hair transplant

- suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g.
alcoholic hepatitis, Wilson disease, Hemochromatosis…etc)

- serum creatinine >1.5mg/dL

- refusal to undergo liver biopsy

- lack of informed consent