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
Who is this study for? Adolescents with chronic hepatitis B
What treatments are being studied? Tenofovir alafenamide
Status: Recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Rady Childrens Hospital
RECRUITING
San Diego
University of California, San Francisco (UCSF)
ACTIVE_NOT_RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
ACTIVE_NOT_RECRUITING
Aurora
Florida
University of Miami/Schiff Center for Liver Diseases
WITHDRAWN
Miami
AdventHealth Medical Group
WITHDRAWN
Orlando
Georgia
Children's Healthcare of Atlanta
WITHDRAWN
Atlanta
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Minnesota
University of Minnesota Masonic Children's Hospital
WITHDRAWN
Minneapolis
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Nebraska
Children's Hospital & Medical Center
WITHDRAWN
Omaha
New York
The Children's Hospital at Montefiore
COMPLETED
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
ACTIVE_NOT_RECRUITING
Cincinnati
Nationwide Children's Hospital
COMPLETED
Columbus
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
COMPLETED
Nashville
Texas
Children's Medical Center
WITHDRAWN
Dallas
Cook Children's Medical Center
COMPLETED
Fort Worth
Texas Children's Hospital - Main Hospital
RECRUITING
Houston
American Research Corporation at Texas Liver Institute
COMPLETED
San Antonio
Washington
Seattle Children's Hospital
RECRUITING
Seatlle
West Virginia
West Virginia University Hospitals
WITHDRAWN
Morgantown
Other Locations
Belgium
Cliniques Universitaires Saint-LUC UCL
COMPLETED
Brussels
Canada
The Hospital for Sick Children
WITHDRAWN
Toronto
BC Children's Hospital
WITHDRAWN
Vancouver
Hong Kong Special Administrative Region
Prince of Wales Hospital
COMPLETED
Shatin
India
GCS Medical Hospital & Research Center
WITHDRAWN
Ahmedabad
SR Kalla Memorial Gastro And General Hospital
WITHDRAWN
Jaipur
Pratha Gastro Liver Center
WITHDRAWN
Kanpur
Institute of Post Graduation Medical Education & Research
RECRUITING
Kolkata
M. V Hospital and Research Center
RECRUITING
Lucknow
LTMMC & LTMG Hospital
ACTIVE_NOT_RECRUITING
Mumbai
Seth GS Medical College and KEM Hospital
RECRUITING
Mumbai
Khalatkar Hospital
RECRUITING
Nagpur
Midas Multispecility Hospital PVT. LTD.
WITHDRAWN
Nagpur
Nandita Hospital and Research Centre
WITHDRAWN
Nagpur
All India Institute of Medical Sciences
RECRUITING
New Delhi
SIDS Hospital and Research Centre
RECRUITING
Surat
Samvedna Hospital
RECRUITING
Varanasi
Italy
AOU di Bologna - Policlinico S. Orsola Malpighi - Dipartimento Malattic dell'Apparato Digerente e Medicina Intema
WITHDRAWN
Bologna
New Zealand
Auckland Clinical Studies Limited
WITHDRAWN
Auckland
Republic of Korea
Kyungpook National University Hospital
COMPLETED
Daegu
Asan Medical Center
COMPLETED
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
WITHDRAWN
Seoul
Severance Hospital, Yonsei University Health System
WITHDRAWN
Seoul
Romania
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
ACTIVE_NOT_RECRUITING
Bucharest
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
ACTIVE_NOT_RECRUITING
Bucharest
Russian Federation
Krasnoyarsk Regional Clinical Center of Maternal and Child Welfare
WITHDRAWN
Krasnoyarsk
Federal Budgetary Institution of Science Central Scientific-Research Institute of Epidemiology
WITHDRAWN
Moscow
Federal Research Centre of Nutrition, Biotechnology and Food Safety
COMPLETED
Moscow
Scientific Center of Children's Health of the Ministry of Health of the Russian Federation
WITHDRAWN
Moscow
Federal Budgetary Scientific Institution Pasteur St. Petersburg Scientific Research Institute of Epidemiology and Microbiology
WITHDRAWN
Saint Petersburg
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
COMPLETED
Saint Petersburg
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
COMPLETED
Tatarstan
Limited Medical Company Hepatolog
COMPLETED
Tolyatti
Taiwan
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
COMPLETED
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Mackay Memorial Hospital
WITHDRAWN
Taipei
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan District
Contact Information
Primary
Gilead Study Team
GS-US-320-1092@gilead.com
Time Frame
Start Date: 2016-11
Estimated Completion Date: 2029-10
Participants
Target number of participants: 150
Treatments
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)~The study has reopened and recruitment is initiated only for this cohort for ≥ 10 to \< 14 kg at this time.
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.
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences