Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
NCT ID: NCT02479880
Last Updated: 2019-05-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
30 participants
INTERVENTIONAL
2015-07-03
2018-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Tenofovir DF
300 mg tablet administered orally once daily for up to 96 weeks
DEXA Scan
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
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.
Tenofovir DF
300 mg tablet administered orally once daily for up to 96 weeks
DEXA Scan
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Interventions
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Tenofovir DF
300 mg tablet administered orally once daily for up to 96 weeks
DEXA Scan
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
12 Years
15 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Cliniques Universitaries Saint- Luc, Departem Pediatrie
Brussels, , Belgium
Hopital Femmes Meres Enfants
Bron, , France
Attikon General Hospital Of Athens
Chaïdári, , Greece
Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Grigore Alexandrescu Childrens Emergency Clinical Hospital
Bucharest, , Romania
Spitatul Clinic de Boli Infectioase Constanta
Constanța, , Romania
Institutul de Gastrenterologie si Hepatologie Iasi
Iași, , Romania
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital de Meixoeiro
Vigo, , Spain
Birmingham Children's Hospital NHS Trust
Birmingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-004939-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-EU-174-1403
Identifier Type: -
Identifier Source: org_study_id
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