A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 18
Updated:5/4/2018
Start Date:June 30, 2007
End Date:September 4, 2017

Use our guide to learn which trials are right for you!

Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

The purpose of this clinical study is to determine the appropriate doses of entecavir to use
in children and adolescents. Safety, tolerability and efficacy will also be studied


Inclusion Criteria:

- 2-18 years of age

- Group A: Lamivudine naive (<1 week of Lamivudine) and not within 24 weeks of
screening; Group B: Lamivudine experienced (> 12 weeks of Lamivudine); Group C:
nucleoside/nucleotide experienced (> 12 weeks of nucleoside/tide therapy) added as a
country-specific protocol amendment (not all sites had Group C).

- HBV Deoxyribonucleic acid (DNA) ≥ 100000 copies/mL; ≥ 10000 copies for
nucleoside/nucleotide experienced (Group C)

- Detectable Hepatitis B surface antigen (HBsAg) for 24 weeks prior to screening

- Hepatitis B e antigen (HBeAg) positive

- Compensated liver and renal function

- Elevated alanine aminotransferase (ALT) at screening and during the 24 weeks prior to
screening (for Groups A and B)

Exclusion Criteria:

- Coinfection with Human immunodeficiency virus (HIV), Hepatitis C virus (HCV),
Hepatitis D Virus (HDV)

- Children who were breastfed while their mother received Lamivudine, or children whose
mothers received Lamivudine during pregnancy
We found this trial at
10
sites
Buenos Aires,
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials