A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic HBV-Infection

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: March 2, 2010
Last updated: May 30, 2013
Last verified: May 2013

The purpose of this study is to determine the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B infection

Condition Intervention Phase
Chronic Hepatitis B Virus, Pediatric
Drug: Entecavir
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The proportion of subjects who achieve: 1) HBV DNA < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay; and 2) HBeAg seroconversion [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with HBV DNA < 50 IU/mL [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HBV DNA < LOQ [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with serum ALT < = 1 x ULN [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HBe seroconversion [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieved sustained HBeAg seroconversion during off-treatment follow-up among subjects who achieved HBe seroconversion at end of treatment [ Time Frame: At 5 years of study participation ] [ Designated as safety issue: No ]
  • The number and percent of subjects with adverse events, serious adverse events, discontinuations due to adverse events, and HBV disease progression [ Time Frame: At Week 48 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who maintained HBeAg seroconversion at Week 96 (end of blinded therapy) among subjects who achieved HBeAg seroconversion [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
  • Histological analysis among subjects with available liver biopsy [ Time Frame: At 5 years of study participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: July 2010
Estimated Study Completion Date: April 2018
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir Drug: Entecavir
Tablets/Oral Solution, Oral, 0.015 mg/kg up to 0.5 mg, once daily, 96-144 weeks, depending on response
Other Names:
  • Baraclude
  • BMS-200475
Placebo Comparator: Placebo Drug: Placebo
Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response


Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 2 - < 18 years of age, male or female
  • HBsAg-positive
  • Detectable HBeAg, and no detectable anti-HBe antibodies
  • ALT 1.5 - <10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
  • Evidence of the presence of HBV DNA at least 4 weeks before screening and > 100,000 copies/mL at screening


  • Any prior therapy with ETV
  • > 12 weeks of prior therapy with any nucleoside or nucleotide antiviral aget
  • Therapy with interferon alpha, thymosin alpha, or nucletos[t]ide antiviral agents within 24 weeks of screening
  • Coinfection with HIV, HCV, HDV
  • Decompensated liver disease
  • Liver transplant recipients
  • Other forms of acute and chronic conditions which may cause increased ALT
  • Children who were breastfed while their mother received lamivudine, or children whose mother received lamivudine during pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079806

  Hide Study Locations
United States, California
University Of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Connecticut Children'S Medical Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children'S National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32611
United States, Georgia
Romero, Rene
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University School Of Medicine / Riley Hospital
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins School Of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children'S Hospital Of Boston
Boston, Massachusetts, United States, 02115
Shah, Uzma
Boston, Massachusetts, United States, 02114
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Levine Children'S Hospital At Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children'S Hospital
Houston, Texas, United States, 77030
United States, Virginia
Inova Fairfax Hospital For Children
Fairfax, Virginia, United States, 22031
Local Institution
Bunos Aires, Buenos Aires, Argentina, 1425
Local Institution
Bruxelles, Belgium, 1200
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Local Institution
Mainz, Rheinland Pfalz, Germany, 55131
Local Institution
Starnberg, Germany, 82319
Local Institution
Wuppertal, Germany, 42283
Local Institution
Thesaloniki, Greece, 54635
Local Institution
Guwahati, India, 781006
Local Institution
Hyderabad, India, 500029
Local Institution
Beer-Sheva, Israel, 84101
Local Institution
Petach Tikva, Israel, 49202
Local Institution
Zefat, Israel, 13110
Korea, Republic of
Local Institution
Daegu, Korea, Republic of, 700-721
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Bydgoszcz, Poland, 85-030
Local Institution
Krakow, Poland, 31-202
Local Institution
Wroclaw, Poland, 50-345
Local Institution
Bucharest, Romania, 011743
Local Institution
Iasi, Romania, 700309
Local Institution
Timisoara, Romania, 300011
Russian Federation
Local Institution
Moscow, Russian Federation, 117198
Local Institution
Moscow, Russian Federation, 111123
Local Institution
Novokuznetsk, Russian Federation, 654063
Local Institution
St. Petersburg, Russian Federation, 197022
Local Institution
Tainan, Taiwan, 704
Local Institution
Taipei, Taiwan, 100
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
Birmingham, West Midlands, United Kingdom, B4 6NH
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01079806     History of Changes
Other Study ID Numbers: AI463-189
Study First Received: March 2, 2010
Last Updated: May 30, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Greece: Ethics Committee
Greece: National Organization of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
India: Central Drugs Standard Control Organization
India: Indian Council of Medical Research
Israel: Israeli Health Ministry Pharmaceutical Administration
Korea: Food and Drug Administration
Poland: National Institute of Medicines
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014