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Recruiting Phase 2 NCT02932150

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Hepatitis B

Sponsor: Gilead Sciences

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 11
Belgium (1)
Cliniques Universitaires Saint-LUC UCL
Brussels
COMPLETED
Canada (1)
The Hospital for Sick Children
Toronto
WITHDRAWN
Hong Kong (1)
Prince of Wales Hospital
Shatin
COMPLETED
India (1)
GCS Medical Hospital & Research Center
Ahmedabad
WITHDRAWN
Italy (1)
AOU di Bologna - Policlinico S. Orsola Malpighi - Dipartimento Malattic dell'Apparato Digerente e Medicina Intema
Bologna
WITHDRAWN
New Zealand (1)
Auckland Clinical Studies Limited
Auckland
WITHDRAWN
Romania (1)
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest
ACTIVE_NOT_RECRUITING
Russia (1)
Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare
Krasnoyarsk
WITHDRAWN
South Korea (1)
Kyungpook National University Hospital
Daegu
COMPLETED
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United States (1)
Children's Hospital of Los Angeles
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
01.11.2016
Completion date
01.10.2029
Registry ID
NCT02932150
Source
anzctr
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