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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004939-39 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir DF | Drug | 300 mg tablet administered orally once daily for up to 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaries Saint- Luc, Departem Pediatrie | Brussels | 1200 | Belgium | |||
| Hopital Femmes Meres Enfants |
35 participants were screened.
Participants were enrolled at study sites in Europe. The first participant was screened on 03 July 2015. The last study visit occurred on 11 April 2018. The study did not achieve targeted enrollment as it was prematurely terminated by the Pharmacovigilance Risk Assessment Committee (PRAC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenofovir DF + Increased Bone/Renal Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body dual-energy x-ray absorptiometry (DXA) 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 were managed according to local standards of care. |
| FG001 | Tenofovir DF + Prespecified Bone Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set included participants who were randomized into the study and received at least one dose of tenofovir DF.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenofovir DF + Increased Bone/Renal Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA 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 were managed according to local standards of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96 | Participants in the Safety Analysis Set (participants who were randomized into the study and received at least one dose of tenofovir DF) with available data were analyzed. | Posted | Number | percentage of participants | Baseline to Week 96 |
|
Up to 96 weeks plus 30 days
Safety Analysis Set included participants who were randomized into the study and received at least one dose of tenofovir DF.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenofovir DF + Increased Bone/Renal Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA 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 were managed according to local standards of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calcinosis | General disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Nov 3, 2014 | Jan 25, 2019 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Mar 10, 2015 | Jan 25, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2018 | Jan 25, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| DEXA Scan | Radiation | Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points |
|
| 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 |
| BG001 | Tenofovir DF + Prespecified Bone Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Tenofovir DF + Prespecified Bone Monitoring |
One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care. |
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 10 |
| 15 |
| EG001 | Tenofovir DF + Prespecified Bone Monitoring | One 300 mg tablet given once daily for up to 96 weeks + laboratory bone biomarker testing and lumbar spine and whole-body DXA scans at baseline, Week 48, and Week 96. With the exception of pre-specified bone monitoring, participants were managed according to local standards of care. | 0 | 15 | 2 | 15 | 10 | 15 |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |