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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
History of Changes

March 2, 2010
May 30, 2013
July 2010
March 2013   (final data collection date for primary outcome measure)
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 ]
The proportion of subjects who have achieved both HBV DNA < 50 IU/mL and HBeAg seroconversion [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01079806 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The proportion of subjects with serum ALT ≤ 1 times the upper limit of normal [ Time Frame: At Week 48 ] [ 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: Day 1 through Week 48 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic HBV-Infection
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

The purpose of this study is to determine the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B infection
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis B Virus, Pediatric
  • 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
  • Drug: Placebo
    Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response
  • Active Comparator: Entecavir
    Intervention: Drug: Entecavir
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
April 2018
March 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Canada,   Germany,   Greece,   India,   Israel,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Taiwan,   United Kingdom
 
NCT01079806
AI463-189
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP