Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Launched by GILEAD SCIENCES · Oct 11, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tenofovir alafenamide (TAF) to see how well it works for treating chronic hepatitis B virus (CHB) infection in children and teenagers. The researchers want to find out if TAF is effective and safe compared to a placebo, which is a dummy treatment with no active medication. They are looking for participants aged between 2 and 17 years who have been diagnosed with CHB for at least six months and meet certain weight and health criteria.

Eligible participants include boys and girls who weigh at least 10 kg (about 22 lbs) and have specific test results showing they have CHB. The study is currently recruiting, and if someone joins, they will receive either TAF or a placebo for a certain period while being monitored for safety and effectiveness. Parents or guardians will need to give permission, and participants will need to follow the study guidelines closely. This trial is an important step in understanding how TAF can help young people with chronic hepatitis B.

Gender

ALL

Eligibility 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 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.