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

NCT00423891 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AI463-028
• Study Type: interventional
• Target: 64
• Locations: 8 countries
• Sites: 19

Brief Summary

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

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment

  AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.

  Day 1 to Week 120

Secondary Outcomes (21)

• Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort

  Day 14

• Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort

  Day 14

• Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort

  Day 14

• Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort

  At 2 weeks

• Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants

  Baseline to Week 96

Study Arms (1)

Arm 1: Entecavir

EXPERIMENTAL

Drug: Entecavir

Interventions

Entecavir DRUG

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

Also known as: Baraclude, BMS-200475

Arm 1: Entecavir

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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) added as a country-specific protocol amendment (not all sites had Group C).
• 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) at screening and during the 24 weeks prior to screening (for Groups A and B)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (19)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Connecticut Children'S Medical Center

Hartford, Connecticut, 06106, United States

Location

University Of Florida

Gainesville, Florida, 32610, United States

Location

Johns Hopkins School Of Medicine

Baltimore, Maryland, 21287, United States

Location

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Mount Sinai School Of Medicine

New York, New York, 10029, United States

Location

Children'S Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University Of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Local Institution

Buenos Aires, 1425, Argentina

Location

Local Institution

Brussels, 1200, Belgium

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90035, Brazil

Location

Local Institution

Sco Paulo, São Paulo, 05403, Brazil

Location

Local Institution

Toronto, Ontario, M5G 1X8, Canada

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Local Institution

Taipei, 100, Taiwan

Location

Local Institution

London, Greater London, SE5 9RS, United Kingdom

Location

Local Institution

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: June 30, 2007
• Primary Completion: August 31, 2013
• Study Completion: September 4, 2017
• Last Updated: May 2, 2018
• Results First Posted: August 7, 2014

Record last verified: 2018-03

Locations

AR (1); TW (1); US (9); BR (2); BE (1); GB (2); CA (1); KR (2)