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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Gilead Sciences
- Enrollment
- 30
- Locations
- 11
- Primary Endpoint
- Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •12 to <16 years of age
- •Documented chronic hepatitis B virus (HBV) infection
- •Weight ≥ 35 kg
- •Able to swallow oral tablets
- •Negative pregnancy test for females of childbearing potential
- •Adequate kidney (renal) function
- •Parent or legal guardian of potential study subjects able to provide written informed consent
Exclusion Criteria
- •Previously received tenofovir DF
- •Sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study
- •Females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study
- •Known hypersensitivity to tenofovir DF, the metabolites or formulation excipients
- •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
Arms & Interventions
Tenofovir DF + increased bone/renal monitoring
Participants will receive tenofovir DF, plus laboratory bone biomarker testing and lumbar spine and whole-body DEXA scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants will be managed according to local standards of care.
Intervention: Tenofovir DF (Drug)
Tenofovir DF + increased bone/renal monitoring
Participants will receive tenofovir DF, plus laboratory bone biomarker testing and lumbar spine and whole-body DEXA scans every 24 weeks from baseline to Week 96 (5 scans), and monitoring of renal function at 4 and 12 weeks after baseline and every 12 weeks thereafter. With the exception of an enhanced monitoring protocol for bone and renal outcomes, participants will be managed according to local standards of care.
Intervention: DEXA Scan (Radiation)
Tenofovir DF + prespecified bone monitoring
Participants will receive tenofovir DF, plus laboratory bone biomarker testing and lumbar spine and whole-body DEXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants will be managed according to local standards of care.
Intervention: Tenofovir DF (Drug)
Tenofovir DF + prespecified bone monitoring
Participants will receive tenofovir DF, plus laboratory bone biomarker testing and lumbar spine and whole-body DEXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants will be managed according to local standards of care.
Intervention: DEXA Scan (Radiation)
Outcomes
Primary Outcomes
Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
Time Frame: Baseline to Week 96
Secondary Outcomes
No secondary outcomes reported