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Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

NCT01522625 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-02-12

No results posted yet for this study

Summary

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Conditions

Interventions

DRUG

tenofovir disoproxil fumarate 300mg per day

tenofovir disoproxil fumarate 300mg per day for 3 years

DRUG

Placebo

Placebo, identical to TDF in appearance, once daily for 3years

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Taipei Institute of Pathology

    collaborator OTHER_GOV

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Yao-Chun Hsu, MD, MSc · E-Da Hospital, Kaohsiung, Taiwan

  • Jaw-Town Lin, MD, PhD · National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-11-30
Completion
2018-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01522625 on ClinicalTrials.gov