Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
N/AClinical Study ID
Ages 3-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Positive for HBsAg and HBeAg for more than 6 months prior to baseline
Detectable HBV-DNA (>20,000 IU/mL) as measured by polymerization chain reaction (PCR)or hybridization on at least 2 occasions at least one month apart with the latestdetermination obtained less than or equal to (</=) 42 days prior to baseline
Compensated liver disease (Child-Pugh Class A clinical classification)
Either Liver biopsy performed within 2 years prior to baseline showing no or minimalfibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal toupper limit of normal [ULN]) during the 6 months leading up to baseline (including twoseparate occasions at least 1 month apart over the 6 months prior to baseline).Screening ALT levels must be normal (</= ULN) OR Stable normal ALT levels (</= ULN),during the 1 year leading up to baseline (including three separate occasions at least 1 month apart over the 1 year prior to baseline) and no signs of hepatocellularcarcinoma (HCC), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominalultrasound at screening. Screening ALT levels must be normal (</= ULN)
Exclusion
Exclusion Criteria:
Participants who have received investigational drugs or licensed treatments with antiHBV activity (Exception: Participants who have had a limited [</= 7-day] course ofacyclovir for herpetic lesions more than 1 month before the study baseline visit arenot excluded)
Participants who have participated in any other clinical trial or who have receivedany investigational drug within 6 months prior to baseline
Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudineor entecavir
Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM)antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab oranti-human immunodeficiency virus (HIV) Ab
Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification orclinical evidence such as ascites or varices)
Advanced fibrosis or cirrhosis
Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominalultrasound within 6 months prior to baseline)
History or other evidence of a medical condition associated with chronic liver diseaseother than CHB including metabolic liver diseases such as hemochromatosis, Wilson'sdisease or alpha-1 anti-trypsin deficiency
Active substance abuse within 6 months prior to screening
Sexually active females of childbearing potential and sexually active males who arenot willing to utilize reliable contraception during treatment and for 90 daysfollowing the end of treatment
Females who are pregnant or who are breastfeeding (females of childbearing potentialwho have a positive urine or serum pregnancy test result within 24 hours of baselineare excluded)
Study Design
Connect with a study center
Womens and Childrens Hospital; Department of Gastroenterology
North Adelaide, South Australia 5006
AustraliaSite Not Available
Royal Children's Hospital; Department of Gastroenterology
Melbourne, Victoria 3053
AustraliaSite Not Available
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
Hospital das Clinicas - FMUSP; Instituto da Crianca
Sao Paulo, SP 05403-000
BrazilSite Not Available
Hospital Infantil Dr. Robert Reid Cabral
Santo Domingo, 10101
Dominican RepublicSite Not Available
Ain Shams University Faculty of Medicine, El-Demerdash Hospital; Pediatrics
Cairo, 11566
EgyptSite Not Available
Menoufiya University-National Liver Institute-Puplic Health
Menoufiya, 32511
EgyptSite Not Available
Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II
Essen, 45122
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin
Mainz, 55131
GermanySite Not Available
Dr. von Haunerschen Kinderspital, Kinderchirurgische Klinik und Poliklinik
München, 80337
GermanySite Not Available
Klinikum Starnberg, Klinik für Kinder- und Jugendmedizin
Starnberg, 82319
GermanySite Not Available
HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke
Wuppertal, 42283
GermanySite Not Available
Clinica Privada Dr. Carlos Mejia Villatoro
Ciudad de Guatemala, 01001
GuatemalaSite Not Available
Osmania General Hospital; Department fo Gastroenterology
Hyderabad, Andhra Pradesh 500012
IndiaSite Not Available
St.Jhon Medical College and Hospital; Dept. of Gastroenterology
Bangalore, Karnataka 560034
IndiaSite Not Available
KEM Hospital
Pune, Maharashtra 411011
IndiaSite Not Available
Sparsh Hospital
Bhubaneshwar, Odisha 751007
IndiaSite Not Available
Institute of Child Health; Pediatrics
Kolkata, West Bengal 700017
IndiaSite Not Available
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Hyderabad 12,
IndiaSite Not Available
King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College
Maharashtra, 400012
IndiaSite Not Available
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New Delhi, 110060
IndiaSite Not Available
Soroka Medical Center
Beer Sheva, 8410101
IsraelSite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Rambam Medical Center
Halfa, 31096
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 91031
IsraelSite Not Available
Assaf Harofeh; Gastroenterology
Zerifin, 6093000
IsraelSite Not Available
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive
Bologna, Emilia-Romagna 40138
ItalySite Not Available
ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti
Bergamo, Lombardia 24127
ItalySite Not Available
A.O. Universitaria di Padova; Dip. Salute della Donna e Bambino-S.S.Malattie Infettive Pediatriche
Padova, Veneto 35128
ItalySite Not Available
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofSite Not Available
Asan Medical Center - Oncology
Seoul, 05505
Korea, Republic ofSite Not Available
University Malaya Medical Center; Department of Paediatrics
Kuala Lumpur, 59100
MalaysiaSite Not Available
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, 011743
RomaniaSite Not Available
Emergency Clinical Hospital for Children Cluj-Napoca
Cluj-Napoca, 400177
RomaniaSite Not Available
St. Maria Emergency Clinical Hospital for Children
Iasi, 700309
RomaniaSite Not Available
Louis Turcanu Emergency Clinical Hospital for Children; First Pediatric Clinic
Timisoara, 300011
RomaniaSite Not Available
Arkhangelsk regional clinical hospital;Infections diseases
Arkhangelsk, 163045
Russian FederationSite Not Available
Russian Scientific Center of Roentgenoradiology
Moscow, 117997
Russian FederationSite Not Available
FSI Scientific research Institute of children's infections
Saint Petersburg, 197022
Russian FederationSite Not Available
MC Gepatolog
Samara, 443100
Russian FederationSite Not Available
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St Petersburg,
Russian FederationSite Not Available
National University Hospital, University Children's Medical Institute; Department of Paediatrics
Singapore, 119228
SingaporeSite Not Available
National Taiwan University Hospital; Department of Paediatrics
Taipei, 100
TaiwanSite Not Available
Chang-Gung Memorial Hospital-Linkou; Division of Pediatric Gastroenterology, Dept Pediatrics
Taoyuan County, 333
TaiwanSite Not Available
RAMATHIBODI HOSPITAL; Faculty of Medicine ;DEPT OF PEDIATRICS
Bangkok,
ThailandSite Not Available
Cukurova University Medical School Department of Pediatrics; Pediatric Infectious Diseases
Adana, 01330
TurkeySite Not Available
Ankara University School of Medicine, Pediatrics Department; Pediatric Gastroenterology
Ankara, 06100
TurkeySite Not Available
Gazi Universitesi Tip Fakultesi Pediyatri Anabilim Dalı; Pediyatrik Gastroenteroloji
Ankara, 06500
TurkeySite Not Available
Hacettepe Uni , School of Medicine; Gastroenterology
Ankara, 06100
TurkeySite Not Available
Gaziantep University School of Medicine, Pediatrics Department; Pediatric Gastroenterology
Gaziantep, 27310
TurkeySite Not Available
Dnipropetrovsk Medical Academy; Infections diseases
Dnipropetrovsk, 49006
UkraineSite Not Available
SI Institute of the pediatrics, obstetrics and gynecology
Kyiv, 04050
UkraineSite Not Available
Vinnytsia National Medical University; Infections diseases
Vinnytsia, 21021
UkraineSite Not Available
Birmingham Children'S Hopsital; Liver Unit
Birmingham, B4 6NH
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7AU
United KingdomSite Not Available
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomSite Not Available
North Manchester General Hospital
Manchester, M8 5RB
United KingdomSite Not Available
University of California San Francisco; Department of Pediatrics
San Francisco, California 94158
United StatesSite Not Available
Children's Mercy Hosp Clinics
Kansas City, Missouri 64108
United StatesSite Not Available
Columbia University
New York, New York 10032-3725
United StatesSite Not Available
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
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