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A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00423891
First received: January 16, 2007
Last updated: March 28, 2013
Last verified: October 2011
History of Changes

January 16, 2007
March 28, 2013
June 2007
August 2013   (final data collection date for primary outcome measure)
  • Maximum Observed plasma concentration (Cmax) of ETV will be derived from plasma concentration versus time data [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Cmin) of ETV will be derived from plasma concentration versus time data [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of ETV will be derived from plasma concentration versus time data [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of ETV will be derived from plasma concentration versus time data [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT/F) of ETV will be derived from plasma concentration versus time data [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
  • Number and percent of subjects with Serious Adverse Events and discontinuation due to Adverse Events [ Time Frame: Through Week 120 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters derived from plasma versus time data at 2 weeks
  • Number and percent of subjects with Serious Adverse Events and discontinuation due to Adverse Events
Complete list of historical versions of study NCT00423891 on ClinicalTrials.gov Archive Site
  • Change from baseline of HBV DNA [ Time Frame: Baseline, at weeks 48, upto weeks 96 ] [ Designated as safety issue: No ]
  • Change from baseline of Hepatitis B e antigen (HBeAg) [ Time Frame: Baseline, at weeks 48, upto weeks 96 ] [ Designated as safety issue: No ]
  • Change from baseline of Hepatitis B surface antibody (HBsAg) [ Time Frame: Baseline, at weeks 48, upto weeks 96 ] [ Designated as safety issue: No ]
  • Change from baseline of Alanine aminotransferase (ALT) [ Time Frame: Baseline, at weeks 48, upto weeks 96 ] [ Designated as safety issue: No ]
  • Change from baseline of Hepatitis B e antibody (HBeAb) [ Time Frame: Baseline, at weeks 48, upto weeks 96 ] [ Designated as safety issue: No ]
  • The number and percent of subjects with adverse events, serious adverse events, and laboratory abnormalities [ Time Frame: Through Week 120 ] [ Designated as safety issue: Yes ]
  • HBV DNA at weeks 48 through 96
  • HBeAg at weeks 48 through 96
  • HBsAg at weeks 48 through 96
  • ALT normalization at weeks 48 through 96
Not Provided
Not Provided
 
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
Drug: Entecavir
Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response
Other Names:
  • Baraclude
  • BMS-200475
Experimental: Arm 1: Entecavir
Intervention: Drug: Entecavir
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
64
October 2017
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2-18 years of age
  • Group A: Lamivudine naive (<1 week of Lamivudine) and not within 24 weeks of screening; Group B: Lamivudine experienced (> 12 weeks of Lamivudine); Group C: nucleoside/nucleotide experienced (> 12 weeks of nucleoside/tide therapy)
  • HBV Deoxyribonucleic acid (DNA) ≥ 100000 copies/mL; ≥ 10000 copies for nucleoside/nucleotide experienced (Group C)
  • Detectable Hepatitis B surface antigen (HBsAg) for 24 weeks prior to screening
  • Hepatitis B e antigen (HBeAg) positive
  • Compensated liver and renal function
  • Elevated Alanine aminotransferase (ALT) for 24 weeks prior to screening (for Groups A and B)

Exclusion Criteria:

  • Coinfection with Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis D Virus (HDV)
  • Children who were breastfed while their mother received Lamivudine, or children whose mothers received Lamivudine during pregnancy
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   Korea, Republic of,   Taiwan,   United Kingdom
 
NCT00423891
AI463-028
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2011

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