Clinical Trials in South Korea / NCT02932150
Active, not recruiting
Phase 2
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
NCT02932150 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Chronic Hepatitis B
Investigational drug(s) / intervention(s)
TAFPlacebo
TAF: Administered orally once daily
Placebo: Administered orally once daily
Study 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
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.
Primary outcome measure(s)
- Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24 — Week 24
- Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24 — Week 24
- Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24 — Week 24
- PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A — Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | |
| Rady Childrens Hospital | San Diego | California | |
| University of California, San Francisco (UCSF) | San Francisco | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Indiana University School of Medicine | Indianapolis | Indiana | |
| Johns Hopkins University | Baltimore | Maryland | |
| Children's Mercy Hospital | Kansas City | Missouri | |
| The Children's Hospital at Montefiore | The Bronx | New York | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Nationwide Children's Hospital | Columbus | Ohio | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | |
| Cook Children's Medical Center | Fort Worth | Texas | |
| Texas Children's Hospital - Main Hospital | Houston | Texas | |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | |
| Seattle Children's Hospital | Seattle | Washington | |
| Cliniques Universitaires Saint-LUC UCL | Brussels | Belgium | |
| Prince of Wales Hospital | Shatin | Hong Kong | |
| Institute of Post Graduation Medical Education & Research | Kolkata | India | |
| M. V Hospital and Research Center | Lucknow | India | |
| Seth GS Medical College and KEM Hospital | Mumbai | India | |
| LTMMC & LTMG Hospital | Mumbai | India | |
| Khalatkar Hospital | Nagpur | India | |
| All India Institute of Medical Sciences | New Delhi | India | |
| SIDS Hospital and Research Centre | Surat | India | |
| Samvedna Hospital | Varanasi | India | |
| Spitalul Grigore Alexandrescu-Sectia Pediatrie III | Bucharest | Romania | |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" | Bucharest | Romania | |
| Federal Research Centre of Nutrition, Biotechnology and Food Safety | Moscow | Russia | |
| Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases | Saint Petersburg | Russia | |
| Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov | Tatarstan | Russia | |
| Limited Medical Company Hepatolog | Tolyatti | Russia | |
| Kyungpook National University Hospital | Daegu | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan | |
| Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | |
| National Cheng Kung University Hospital | Tainan | Taiwan | |
| National Taiwan University Hospital | Taipei | Taiwan | |
| Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02932150 on ClinicalTrials.gov ↗ ← All trials in South Korea