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

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00423891

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

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

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

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 19 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure 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:	NCT00423891 History of Changes
Other Study ID Numbers:	AI463-028
Study First Received:	January 16, 2007
Last Updated:	April 30, 2012
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 May 22, 2012