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

Phase 4

Terminated

• Conditions: Hepatitis B
• Interventions: Drug: Tenofovir DF; Radiation: DEXA Scan

• Registration Number: NCT02479880
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Study Start: 2015-07-03
• Primary Completion: 2018-02-28
• Study Completion: 2018-04-11
• Status Verified: 2019-02
• Results First Submitted: 2019-02-21
• Results First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Results First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir DF + increased bone/renal monitoring	Tenofovir DF	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 + prespecified bone monitoring	Tenofovir DF	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 + increased bone/renal monitoring	DEXA Scan	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 + prespecified bone monitoring	DEXA Scan	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Attikon General Hospital Of Athens; 🇬🇷 Chaidari, Greece

Hopital Femmes Meres Enfants; 🇫🇷 Bron, France

Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Birmingham Children's Hospital NHS Trust; 🇬🇧 Birmingham, United Kingdom

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain

Hospital de Meixoeiro; 🇪🇸 Vigo, Spain

Cliniques Universitaries Saint- Luc, Departem Pediatrie; 🇧🇪 Brussels, Belgium

Grigore Alexandrescu Childrens Emergency Clinical Hospital; 🇷🇴 Bucharest, Romania

Spitatul Clinic de Boli Infectioase Constanta; 🇷🇴 Constanta, Romania

Institutul de Gastrenterologie si Hepatologie Iasi; 🇷🇴 Iaşi, Romania

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain