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Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

NCT02479880 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-20

Study results available
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Summary

The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to \< 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.

Conditions

Interventions

DRUG

Tenofovir DF

300 mg tablet administered orally once daily for up to 96 weeks

RADIATION

DEXA Scan

Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-03
Primary Completion
2018-02-28
Completion
2018-04-11

Countries

  • Belgium
  • France
  • Greece
  • Italy
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02479880 on ClinicalTrials.gov