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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02932150
Registration number
NCT02932150
Ethics application status
Date submitted
16/09/2016
Date registered
13/10/2016
Date last updated
7/06/2024
Titles & IDs
Public title
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
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Scientific title
A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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0
2016-000785-37
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Secondary ID [2]
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GS-US-320-1092
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAF
Treatment: Drugs - Placebo
Experimental: TAF (Cohort 1) - Participants (12 to < 18 years) weighing = 35 kg will receive TAF 25 mg tablet for 24 weeks
Placebo Comparator: Placebo (Cohort 1) - Participants (12 to < 18 years) weighing = 35 kg will receive placebo tablet for 24 weeks
Experimental: TAF (Cohort 2 Group 1) - Participants (6 to < 12 years) weighing = 25 kg will receive TAF 25 mg tablet for 24 weeks
Experimental: TAF (Cohort 2 Group 2) - Participants (6 to < 12 years) weighing = 14 kg to < 25 kg will receive TAF 15 mg oral granules for 24 weeks
Experimental: TAF (Cohort 2 Group 3) - Participants (2 to < 6 years) will receive TAF for 24 weeks as follows:
weight = 10 kg to < 14 kg (7.5 mg oral granules)
weight = 14 kg to < 25 kg (15 mg oral granules)
Placebo Comparator: Cohort 2 Placebo - Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.
Experimental: Open-Label TAF - Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.
Treatment: Drugs: TAF
Administered orally once daily
Treatment: Drugs: Placebo
Administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
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Assessment method [1]
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24
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Assessment method [2]
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Timepoint [2]
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Week 24
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Primary outcome [3]
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Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24
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Assessment method [3]
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Timepoint [3]
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Week 24
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Primary outcome [4]
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PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A
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Assessment method [4]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [4]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12
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Secondary outcome [1]
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Percentage of participants experiencing graded laboratory abnormalities
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Assessment method [1]
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Timepoint [1]
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Weeks 24, 48, 96, and 240
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Secondary outcome [2]
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Development as measured by Tanner Stage Assessment
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Assessment method [2]
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Timepoint [2]
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Weeks 24, 48, 96, and 240
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Secondary outcome [3]
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Percentage change from baseline in bone mineral density (BMD) of whole body (minus head) by dual imaging x-ray absorptiometry (DXA)
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Assessment method [3]
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Timepoint [3]
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Baseline; Weeks 24, 48, 96, and 240
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Secondary outcome [4]
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Percentage change from baseline in BMD of lumbar spine by DXA
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Assessment method [4]
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Timepoint [4]
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Baseline; Weeks 24, 48, 96, and 240
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Secondary outcome [5]
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Change from baseline in serum creatinine
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Assessment method [5]
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Timepoint [5]
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Baseline; Weeks 4, 8, 12, 24, 48, 96, and 240
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Secondary outcome [6]
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Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula
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Assessment method [6]
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0
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Timepoint [6]
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Baseline; Weeks 24, 48, 96, and 240
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Secondary outcome [7]
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Incidence of treatment-emergent SAEs in participants treated with TAF or placebo for 24 weeks followed by open-label TAF at Weeks 48, 96 and 240
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Assessment method [7]
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0
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Timepoint [7]
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0
Weeks 48, 96, and 240
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Secondary outcome [8]
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Incidence of treatment-emergentAEs in participants treated with TAF or placebo for 24 weeks followed by open-label TAF at Weeks 48, 96 and 240
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Assessment method [8]
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0
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Timepoint [8]
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0
Weeks 48, 96, and 240
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Secondary outcome [9]
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Change from baseline in retinol-binding protein to creatine ratio at Weeks 4, 8, 12, 24, and 48
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Assessment method [9]
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Timepoint [9]
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Baseline; Weeks 4, 8, 12, 24, and 48
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Secondary outcome [10]
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Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48
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Assessment method [10]
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0
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Timepoint [10]
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Baseline; Weeks 4, 8, 12, 24, and 48
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Secondary outcome [11]
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Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48
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Assessment method [11]
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0
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Timepoint [11]
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Baseline; Weeks 4, 8, 12, 24, and 48
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Secondary outcome [12]
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Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48
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Assessment method [12]
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Timepoint [12]
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Baseline; Weeks 4, 8, 12, 24, and 48
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Secondary outcome [13]
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Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
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Assessment method [13]
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Timepoint [13]
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Weeks 48, 96, and 240
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Secondary outcome [14]
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Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240
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Assessment method [14]
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Timepoint [14]
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Weeks 24, 48, 96, and 240
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Secondary outcome [15]
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Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240
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Assessment method [15]
0
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Timepoint [15]
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Weeks 24, 48, 96, and 240
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Secondary outcome [16]
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Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240
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Assessment method [16]
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Timepoint [16]
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Weeks 24, 48, 96 and 240
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Secondary outcome [17]
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Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240
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Assessment method [17]
0
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Timepoint [17]
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Baseline; Weeks 24, 48, 96, and 240
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Secondary outcome [18]
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Percentage of participants with hepatitis B e antigen (HBeAg) loss and seroconversion to anti-HBe (HBeAG-positive participants only) at Weeks 24, 48, 96, and 240
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Assessment method [18]
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Timepoint [18]
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Weeks 24, 48, 96, and 240
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Secondary outcome [19]
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Percentage of participants with composite endpoint of HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only)
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Assessment method [19]
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Timepoint [19]
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Weeks 24, 48, 96, and 240
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Secondary outcome [20]
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Percentage of participants with composite endpoint of ALT normalization, HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (in HBeAg-positive participants only)
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Assessment method [20]
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0
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Timepoint [20]
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Weeks 24, 48, 96, and 240
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Secondary outcome [21]
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Percentage of participants with hepatitis B surface antigen (HBsAg) loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240
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Assessment method [21]
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Timepoint [21]
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Weeks 24, 48, 96, and 240
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Secondary outcome [22]
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Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240
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Assessment method [22]
0
0
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Timepoint [22]
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0
Weeks 24, 48, 96, and 240
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Secondary outcome [23]
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Incidence of resistance mutations at Weeks 24, 48, 96, and 240
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Assessment method [23]
0
0
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Timepoint [23]
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0
Weeks 24, 48, 96, and 240
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Secondary outcome [24]
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Acceptability of study drug
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Assessment method [24]
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To assess acceptability of study drug, the investigator will ask participants if they were able to taste the medication on a scale of 1-5, how much they like the taste of the medication (1 = dislike very much to 5 = like very much).
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Timepoint [24]
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Baseline; Weeks 4, 24, and 36
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Secondary outcome [25]
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Palatability of study drug
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Assessment method [25]
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To assess palatability of study drug, the investigator will ask participants on a scale of 0-3 how easy it was to swallow the pill (0 = poor to 3 = excellent).
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Timepoint [25]
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Baseline; Weeks 4, 24, and 36
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Secondary outcome [26]
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PK Parameter: AUCtau of tenofovir (TFV)
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Assessment method [26]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [26]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [27]
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PK Parameter: AUClast of TAF and TFV
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Assessment method [27]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [27]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [28]
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PK Parameter: Ctau of TFV
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Assessment method [28]
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [28]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [29]
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PK Parameter: Cmax of TAF and TFV
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Assessment method [29]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [29]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [30]
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PK Parameter: Clast of TAF and TFV
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Assessment method [30]
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Clast is defined as the last observable concentration of drug.
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Timepoint [30]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [31]
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PK Parameter: Tmax of TAF and TFV
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Assessment method [31]
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Tmax is defined as the time of Cmax (the maximum concentration of drug).
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Timepoint [31]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [32]
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PK Parameter: Tlast of TAF and TFV
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Assessment method [32]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [32]
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0
Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [33]
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PK Parameter: ?z of TAF and TFV
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Assessment method [33]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [33]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [34]
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PK Parameter: CL/F of TAF and TFV
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Assessment method [34]
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CL/F is defined as the apparent oral clearance following administration of the drug.
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Timepoint [34]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [35]
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PK Parameter: Vz/F of TAF and TFV
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Assessment method [35]
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Vz/F is defined as the apparent volume of distribution of the drug.
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Timepoint [35]
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0
Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Secondary outcome [36]
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PK Parameter: t1/2 of TAF and TFV
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Assessment method [36]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [36]
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Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 (Cohort 1), and Week 4, 8, or 12 (Cohort 2)
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Eligibility
Key inclusion criteria
Key Inclusion criteria:
- Males and non-pregnant, non-lactating females
- Weight at screening as follows:
- Cohort 1 = = 35 kg (= 77 lbs)
- Cohort 2 Group 1 = = 25 kg (= 55 lbs)
- Cohort 2 Group 2 = = 14 kg to < 25 kg (= 30 lbs to <55 lbs)
- Cohort 2 Group 3 = = 10 kg to < 14 kg (= 22 lbs to < 30 lbs) or
- 14 kg to < 25 kg (= 30 lbs to < 55 lbs)
- Willing and able to provide written informed consent/assent (child and parent/legal
guardian)
- Documented evidence of CHB (eg, HBsAg-positive for = 6 months)
- HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
- Screening HBV DNA = 2 × 10^4 IU/mL
- Screening serum ALT > 45 U/L (> 1.5 × ULN: 30 U/L) and = 10 × ULN (by central
laboratory range)
- Treatment-naive or treatment-experienced will be eligible for enrollment.
- Estimated creatinine clearance (CLCr) = 80 mL/min/1.73m^2 (using the Schwartz formula)
- Normal ECG
Key
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Minimum age
2
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Females who are pregnant or breastfeeding
- Males and females of reproductive potential who are unwilling to use an "effective",
protocol-specified method(s) of contraception during the study.
- Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
- Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is <
50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an
imaging study is required)
- Any history of, or current evidence of, clinical hepatic decompensation
- Abnormal hematological and biochemical parameters
- Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin
deficiency, cholangitis)
- Received solid organ or bone marrow transplant
- Currently receiving therapy with immunomodulators (eg, corticosteroids), or
immunosuppressants
- Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion
of the Investigator
- Malignancy within the 5 years prior to screening. Individuals under evaluation for
possible malignancy are not eligible.
- Current alcohol or substance abuse judged by the investigator to potentially interfere
with subject compliance.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2029
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Maryland
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Minnesota
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Missouri
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Nebraska
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Ohio
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Washington
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Country [15]
0
0
United States of America
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State/province [15]
0
0
West Virginia
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Brussels
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Country [17]
0
0
Canada
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State/province [17]
0
0
Toronto
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Country [18]
0
0
Canada
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State/province [18]
0
0
Vancouver
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Country [19]
0
0
Hong Kong
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State/province [19]
0
0
Shatin
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Country [20]
0
0
India
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State/province [20]
0
0
Ahmedabad
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Country [21]
0
0
India
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State/province [21]
0
0
Jaipur
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Country [22]
0
0
India
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State/province [22]
0
0
Kanpur
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Country [23]
0
0
India
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State/province [23]
0
0
Kolkata
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Country [24]
0
0
India
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State/province [24]
0
0
Lucknow
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Country [25]
0
0
India
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State/province [25]
0
0
Mumbai
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Country [26]
0
0
India
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State/province [26]
0
0
Nagpur
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Country [27]
0
0
India
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State/province [27]
0
0
New Delhi
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Country [28]
0
0
India
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State/province [28]
0
0
Surat
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Country [29]
0
0
India
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State/province [29]
0
0
Varanasi
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Country [30]
0
0
Italy
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State/province [30]
0
0
Bologna
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Country [31]
0
0
Korea, Republic of
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State/province [31]
0
0
Daegu
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Country [32]
0
0
Korea, Republic of
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State/province [32]
0
0
Seoul
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Country [33]
0
0
New Zealand
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State/province [33]
0
0
Auckland
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Country [34]
0
0
Romania
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State/province [34]
0
0
Bucharest
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Country [35]
0
0
Russian Federation
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State/province [35]
0
0
Krasnoyarsk
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Country [36]
0
0
Russian Federation
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State/province [36]
0
0
Moscow
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Country [37]
0
0
Russian Federation
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State/province [37]
0
0
Saint-Petersburg
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Country [38]
0
0
Russian Federation
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State/province [38]
0
0
Tatarstan
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Country [39]
0
0
Russian Federation
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State/province [39]
0
0
Tolyatti
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Country [40]
0
0
Taiwan
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State/province [40]
0
0
Kaohsiung City
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Country [41]
0
0
Taiwan
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State/province [41]
0
0
Kaohsiung
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Country [42]
0
0
Taiwan
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State/province [42]
0
0
Tainan
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Country [43]
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Taiwan
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State/province [43]
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Taipei
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Country [44]
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Taiwan
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State/province [44]
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Taoyuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goals of this clinical study are to compare the effectiveness, safety and tolerability of
study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to
learn more about the dosing levels in children.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02932150
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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0
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Phone
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Fax
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Email
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0
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Contact person for public queries
Name
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Gilead Study Team
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Address
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0
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Country
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0
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02932150
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