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

• Status: Terminated
• Trial end date: 2018-04-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Key Inclusion Criteria:

1. 12 to <16 years of age

2. Documented chronic hepatitis B virus (HBV) infection

3. Weight ≥ 35 kg

4. Able to swallow oral tablets

5. Negative pregnancy test for females of childbearing potential

6. Adequate kidney (renal) function

7. Parent or legal guardian of potential study subjects able to provide written informed consent

Key Exclusion Criteria:

1. Previously received tenofovir DF

2. Sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study

3. Females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study

4. Known hypersensitivity to tenofovir DF, the metabolites or formulation excipients

5. Any condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with treatment requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply