Hepatitis BPhase 4NCT02479880
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
A Phase 4 study testing Tenofovir DF and DEXA Scan in people with Hepatitis B, run by Gilead Sciences at 11 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir DF and DEXA Scan
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 3 Jul 2015to 11 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Romania3 sites
Grigore Alexandrescu Childrens Emergency Clinical Hospital
Bucharest, 11743
Spitatul Clinic de Boli Infectioase Constanta
Constanța, 900708
Institutul de Gastrenterologie si Hepatologie Iasi
Iași, 700111
Spain3 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Sant Joan de Déu
Barcelona, 8950
Hospital de Meixoeiro
Vigo, 36200
Belgium1 site
Cliniques Universitaries Saint- Luc, Departem Pediatrie
Brussels, 1200
United Kingdom1 site
Birmingham Children's Hospital NHS Trust
Birmingham, B4 6NH
About this study
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
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.
- Conditions
- Hepatitis B
- Being tested
- Tenofovir DF, DEXA Scan
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir DFDrug
Also called Viread®
300 mg tablet administered orally once daily for up to 96 weeks
DEXA ScanRadiation
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir DF + increased bone/renal monitoring | Other | 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. Receives: Drug: Tenofovir DF; Radiation: DEXA Scan |
| Tenofovir DF + prespecified bone monitoring | Other | 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. Receives: Drug: Tenofovir DF; Radiation: DEXA Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
Measured: Baseline to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start3 Jul 2015
- Primary completion28 Feb 2018
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479880
- Sponsor's protocol ID
- GS-EU-174-1403
- Other IDs
- 2014-004939-39, 2014
- Status last verified
- Feb 2019
- First submitted
- 17 Jun 2015
- Last updated
- 20 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02479880
- Acronym / sponsor ID
- GS-EU-174-1403
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir DF + increased bone/renal monitoring | Other | Drug: Tenofovir DF, Radiation: DEXA ScanParticipants 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 | Other | Drug: Tenofovir DF, Radiation: DEXA ScanParticipants 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir DFAlso: Viread®300 mg tablet administered orally once daily for up to 96 weeks | Drug | Tenofovir DF + increased bone/renal monitoring, Tenofovir DF + prespecified bone monitoring |
| DEXA ScanDual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points | Radiation | Tenofovir DF + increased bone/renal monitoring, Tenofovir DF + prespecified bone monitoring |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir DF and DEXA Scan in people with Hepatitis B, run by Gilead Sciences at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Romania, Spain, Belgium, France, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.