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.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01079806
First received: March 2, 2010
Last updated: May 30, 2013
Last verified: May 2013
  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:


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

  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

  Show 43 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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
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 April 17, 2014