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

NCT02463019 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-06-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate

Sponsors & Collaborators

  • Taipei Institute of Pathology

    collaborator OTHER_GOV

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Jaw-Town Lin, MD., PhD · Fu Jen Catholic University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-01-31
Completion
2020-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463019 on ClinicalTrials.gov