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
2 other identifiers
interventional
30
7 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2015
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2018
CompletedResults Posted
Study results publicly available
May 20, 2019
CompletedMay 20, 2019
February 1, 2019
2.7 years
June 17, 2015
February 21, 2019
February 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
Baseline to Week 96
Study Arms (2)
Tenofovir DF + increased bone/renal monitoring
OTHERParticipants 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.
Tenofovir DF + prespecified bone monitoring
OTHERParticipants 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.
Interventions
300 mg tablet administered orally once daily for up to 96 weeks
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (11)
Cliniques Universitaries Saint- Luc, Departem Pediatrie
Brussels, 1200, Belgium
Hopital Femmes Meres Enfants
Bron, 69677, France
Attikon General Hospital Of Athens
Chaïdári, 12462, Greece
Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Grigore Alexandrescu Childrens Emergency Clinical Hospital
Bucharest, 11743, Romania
Spitatul Clinic de Boli Infectioase Constanta
Constanța, 900708, Romania
Institutul de Gastrenterologie si Hepatologie Iasi
Iași, 700111, Romania
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan de Déu
Barcelona, 8950, Spain
Hospital de Meixoeiro
Vigo, 36200, Spain
Birmingham Children's Hospital NHS Trust
Birmingham, B4 6NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 24, 2015
Study Start
July 3, 2015
Primary Completion
February 28, 2018
Study Completion
April 11, 2018
Last Updated
May 20, 2019
Results First Posted
May 20, 2019
Record last verified: 2019-02