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
  Purpose

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


Condition Intervention Phase
Hepatitis B, Chronic
Drug: Entecavir
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: June 2007
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Entecavir 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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423891

  Hide Study Locations
Locations
United States, California
Dr. Philip Rosenthal
San Francisco, California, United States, 94143
United States, Connecticut
Connecticut Children'S Medical Center
Hartford, Connecticut, United States, 06106
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
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
United States, New York
Mount Sinai School Of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1118
Local Institution
Buenos Aires, Argentina, C1181ACH
Local Institution
Buenos Aires, Argentina, 1425
Belgium
Local Institution
Bruxelles, Belgium, 1200
Brazil
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Local Institution
Sco Paulo, Sao Paulo, Brazil, 05403
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1X8
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Seoul, Korea, Republic of, 135-710
Taiwan
Local Institution
Taipei, Taiwan, 100
Local Institution
Tao-Yuan County, Taiwan, 333
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00423891     History of Changes
Other Study ID Numbers: AI463-028
Study First Received: January 16, 2007
Last Updated: March 28, 2013
Health Authority: 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 July 29, 2014