Clinical Trials List
Protocol NumberGS-US-320-1092
NCT Number(ClinicalTrials.gov Identfier)NCT02932150
Active
2017-02-01 - 2024-12-31
Phase III
Recruiting5
Terminated1
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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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/24
Investigators and Locations
Co-Principal Investigator
- YEN-HSUAN NI 無
- Huey-Ling Chen 無
- 吳嘉峰 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃瑞妍 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yuan-Yow Chiou Division of Pediatrics
- 陳建旭 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Ming-Wei Lai
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
chronic hepatitis B
Objectives
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.
Test Drug
Tenofovir Alafenamide
Active Ingredient
Tenofovir Alafenamide
Dosage Form
Tablets
Dosage
25mg
Endpoints
Primary Outcome Measures
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24
Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24
PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A
Secondary Outcome Measures
Percentage of participants experiencing graded laboratory abnormalities
Development as measured by Tanner Stage Assessment
Percentage change from baseline in bone mineral density (BMD) of whole body (minus head) by dual imaging x-ray absorptiometry (DXA)
Percentage change from baseline in BMD of lumbar spine by DXA
Change from baseline in serum creatinine
Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula
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
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
Change from baseline in retinol-binding protein to creatine ratio at Weeks 4, 8, 12, 24, and 48
Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48
Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48
Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48
Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240
Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240
Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240
Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240
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
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)
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)
Percentage of participants with hepatitis B surface antigen (HBsAg) loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240
Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240
Incidence of resistance mutations at Weeks 24, 48, 96, and 240
Acceptability of study drug
Palatability of study drug
PK Parameter: AUCtau of tenofovir (TFV)
PK Parameter: AUClast of TAF and TFV
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24
Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24
Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24
PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A
Secondary Outcome Measures
Percentage of participants experiencing graded laboratory abnormalities
Development as measured by Tanner Stage Assessment
Percentage change from baseline in bone mineral density (BMD) of whole body (minus head) by dual imaging x-ray absorptiometry (DXA)
Percentage change from baseline in BMD of lumbar spine by DXA
Change from baseline in serum creatinine
Change from baseline in estimated glomerular filtration rate (eGFR) by the Schwartz formula
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
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
Change from baseline in retinol-binding protein to creatine ratio at Weeks 4, 8, 12, 24, and 48
Change from baseline in beta-2-microglobulin to creatine ratio at Weeks 4, 8, 12, 24, and 48
Change from baseline in glucose at Weeks 4, 8, 12, 24, and 48
Change from baseline in phosphate at Weeks 4, 8, 12, 24, and 48
Percentage of participants with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
Proportion of participants with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240
Percentage of participants with alanine aminotransferase (ALT) normalization at Weeks 24, 48, 96, and 240
Composite endpoint of percentage of participants with ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240
Change from baseline in fibrosis as assessed by FibroTest at Weeks 24, 48, 96, and 240
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
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)
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)
Percentage of participants with hepatitis B surface antigen (HBsAg) loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240
Percentage of participants with qHBsAg log10 IU/mL at Weeks 24, 48, 96, and 240
Incidence of resistance mutations at Weeks 24, 48, 96, and 240
Acceptability of study drug
Palatability of study drug
PK Parameter: AUCtau of tenofovir (TFV)
PK Parameter: AUClast of TAF and TFV
Inclution Criteria
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
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
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.
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.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
180 participants
