Trials / Terminated
TerminatedNCT02479880
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Pharmacoepidemiology Study to Define the Long-term Safety Profile of Tenofovir Disoproxil Fumarate (Tenofovir DF, Viread®) and Describe the Management of Tenofovir DF-associated Renal and Bone Toxicity in Chronic Hepatitis B (CHB)-Infected Adolescents Aged 12 to <18 Years in Europe
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 12 Years – 15 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-07-03
- Primary completion
- 2018-02-28
- Completion
- 2018-04-11
- First posted
- 2015-06-24
- Last updated
- 2019-05-20
- Results posted
- 2019-05-20
Locations
11 sites across 7 countries: Belgium, France, Greece, Italy, Romania, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02479880. Inclusion in this directory is not an endorsement.