Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent
Conditions
Interventions
Intervention1: TAF 25mg QD orally once daily: Intervention : Cohort 1 (adolescents 12 to 18 years, 35 kg):TAF 25 mg QD orally once daily for 24 Weeks
Cohort 2 Part A
Group 1: Age range- 6 to 12 year
Sponsors
Gilead Sciences Inc
Klinera Global Service India
Eligibility
Inclusion criteria
Inclusion criteria: Age from 2.00 Age to 18.00 Gender both Details: 1 Males and non-pregnant non lactating females 2 Weight at Screening : Cohort 1 (adolescents 12 to 35 kg):TAF 25 mg QD orally once daily for 24 Weeks Cohort 2 Part A Group 1: Age range- 6 to Group 2: Age range- 6 to Group 3: Age range- 2 to 4 Willing and able to provide written informed consent or assent or child and parent or legal guardian 5 Documented evidence of CHB eg HBsAg positive for more than or equal to 6 months 6 HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following: a) Screening HBV DNA = 2 × 104 IU/mL b) Screening serum ALT > 45 U/L ( >1.5 × ULN: 30 U/L) and = 10 × ULN (by central laboratory range) 7 Treatment-naive or treatment experienced will be eligible for Enrolment 8 Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 24 weeks prior to the Baseline visit 9 Estimated creatinine clearance more than or equal to 80 mL per min per 1.73m2 using the Schwartz formula 10 Normal ECG
Exclusion criteria
Exclusion criteria: 1 Females who are breastfeeding 2 Males and females of reproductive potential who are unwilling to use an "effective" protocol-specified methods of contraception during the study 3 Coinfection with hepatitis C virus, HCV, HIV or hepatitis D virus 4 Evidence of hepatocellular carcinoma 5 Any history of or current evidence of clinical hepatic decompensation 6 Abnormal hematological and biochemical parameters, including: a) Hemoglobin b) Absolute neutrophil count c) Platelets = 100,000/mm3 d) AST or ALT > 10 × ULN (by central laboratory range) e) Total bilirubin > 2.5 × ULN f) Albumin g) INR > 1.5 × ULN (unless on stable anticoagulant regimen) 7 Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis) 8 Received solid organ or bone marrow transplant 9 Currently receiving therapy with immunomodulators, e g corticosteroids or immunosuppressants 10 Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator 11 Malignancy within the 5 years prior to screening, Individuals under evaluation for possible malignancy are not eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events in subjects treated with TAF or placebo at Week 24 (Cohort 1) · Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events in subjects treated with TAF or placebo at Week 48 for 24 weeks followed by 24 weeks of open-label TAF (Cohort 2) Timepoint: The primary safety endpoints are Incidence of treatment emergent serious adverse events and treatment emergent adverse events at Week 24 The primary efficacy endpoint is The percentage of subjects with plasma HBV DNA less than 20IU per mL at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of HBV DNA and ALT, Evaluation of glucose, phosphate, retinol-binding protein and beta-2-microglobulin, Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent, percentage change from Baseline in bone mineral densityTimepoint: Weeks 24 48 96 and 240 | — |
Countries
Belgium, Hong Kong, India, Italy, New Zealand, Romania, Russian Federation, Taiwan, United States of America
Contacts
Public ContactPritesh Tailor
Klinera Global Services
Outcome results
None listed