Trial Outcomes & Findings for Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection (NCT NCT02479880)
NCT ID: NCT02479880
Last Updated: 2019-05-20
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline to Week 96
Results posted on
2019-05-20
Participant Flow
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).
35 participants were screened.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
13
|
12
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Tenofovir DF + Increased Bone/Renal Monitoring
n=15 Participants
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.
|
Tenofovir DF + Prespecified Bone Monitoring
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
14 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
14 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 96Population: 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.
Outcome measures
| Measure |
Tenofovir DF + Increased Bone/Renal Monitoring
n=15 Participants
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.
|
Tenofovir DF + Prespecified Bone Monitoring
n=15 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
|
6.7 percentage of participants
|
0 percentage of participants
|
Adverse Events
Tenofovir DF + Increased Bone/Renal Monitoring
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Tenofovir DF + Prespecified Bone Monitoring
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir DF + Increased Bone/Renal Monitoring
n=15 participants at risk
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.
|
Tenofovir DF + Prespecified Bone Monitoring
n=15 participants at risk
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.
|
|---|---|---|
|
General disorders
Calcinosis
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
General disorders
Malaise
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
Other adverse events
| Measure |
Tenofovir DF + Increased Bone/Renal Monitoring
n=15 participants at risk
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.
|
Tenofovir DF + Prespecified Bone Monitoring
n=15 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 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.
|
13.3%
2/15 • 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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Gastrointestinal disorders
Anal fissure
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Gastrointestinal disorders
Dyschezia
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Gastrointestinal disorders
Food poisoning
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • 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.
|
0.00%
0/15 • 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.
|
|
General disorders
Fatigue
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • 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.
|
0.00%
0/15 • 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.
|
|
Immune system disorders
Hypersensitivity
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15 • 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.
|
0.00%
0/15 • 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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • 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.
|
6.7%
1/15 • 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.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Investigations
Bone density decreased
|
0.00%
0/15 • 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.
|
13.3%
2/15 • 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.
|
|
Investigations
Vitamin D decreased
|
13.3%
2/15 • 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.
|
13.3%
2/15 • 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.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 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.
|
13.3%
2/15 • 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.
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/15 • 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.
|
6.7%
1/15 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • 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.
|
6.7%
1/15 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • 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.
|
0.00%
0/15 • 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.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER