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

Primary Purpose

Hepatitis B

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tenofovir DF
DEXA Scan
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis B

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaries Saint- Luc, Departem Pediatrie
  • Hopital Femmes Meres Enfants
  • Attikon General Hospital Of Athens
  • Azienda Ospedaliero-Universitaria di Bologna
  • Grigore Alexandrescu Childrens Emergency Clinical Hospital
  • Spitatul Clinic de Boli Infectioase Constanta
  • Institutul de Gastrenterologie si Hepatologie Iasi
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Sant Joan de Déu
  • Hospital de Meixoeiro
  • Birmingham Children's Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Tenofovir DF + increased bone/renal monitoring

Tenofovir DF + prespecified bone monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96

Secondary Outcome Measures

Full Information

First Posted
June 17, 2015
Last Updated
February 21, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02479880
Brief Title
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
July 3, 2015 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
April 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenofovir DF + increased bone/renal monitoring
Arm Type
Other
Arm Description
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.
Arm Title
Tenofovir DF + prespecified bone monitoring
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Tenofovir DF
Other Intervention Name(s)
Viread®
Intervention Description
300 mg tablet administered orally once daily for up to 96 weeks
Intervention Type
Radiation
Intervention Name(s)
DEXA Scan
Intervention Description
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaries Saint- Luc, Departem Pediatrie
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hopital Femmes Meres Enfants
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Attikon General Hospital Of Athens
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Azienda Ospedaliero-Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Grigore Alexandrescu Childrens Emergency Clinical Hospital
City
Bucharest
ZIP/Postal Code
11743
Country
Romania
Facility Name
Spitatul Clinic de Boli Infectioase Constanta
City
Constanta
ZIP/Postal Code
900708
Country
Romania
Facility Name
Institutul de Gastrenterologie si Hepatologie Iasi
City
Iaşi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
ZIP/Postal Code
8950
Country
Spain
Facility Name
Hospital de Meixoeiro
City
Vigo
ZIP/Postal Code
36200
Country
Spain
Facility Name
Birmingham Children's Hospital NHS Trust
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom

12. IPD Sharing Statement

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

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