Text Size

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

This study is currently recruiting participants.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01079806
First received: March 2, 2010
Last updated: March 28, 2013
Last verified: February 2012
History of Changes
  Purpose

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:

Drug Information available for: Entecavir
U.S. FDA Resources

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
Estimated 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

  Eligibility

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

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

Exclusion:

  • 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

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 48 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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: March 28, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: ANVIA, CONEP
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
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
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013