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A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus 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: June 1, 2017
Last verified: June 2017
March 2, 2010
June 1, 2017
June 30, 2010
March 31, 2013   (Final data collection date for primary outcome measure)
Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 [ Time Frame: At Week 48 ]
Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
The proportion of subjects who have achieved both HBV DNA < 50 IU/mL and HBeAg seroconversion [ Time Frame: At Week 48 ]
Complete list of historical versions of study NCT01079806 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 [ Time Frame: At Week 48 ]
    While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
  • Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 [ Time Frame: At Week 48 ]
    LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
  • Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 [ Time Frame: At Week 48 ]
    While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
  • Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48 [ Time Frame: At Week 48 ]
    HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression [ Time Frame: Day 1 through Week 48 on blinded therapy ]
    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. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.
  • Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) [ Time Frame: Day 1 through Week 48 on blinded therapy ]
    Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= <7. Platelets (/mm^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= <25,000. INR (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= >3. WBC (/mm^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= <1000. Neutrophils (/mm^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= <500.
  • Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) [ Time Frame: Day 1 through Week 48 on blinded therapy ]
    Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4= >10. Bilirubin (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2.5; Grade 3=2.6-5; Grade 4= >5. Albumin (g/dL): Grade 1=3- <LLN; Grade 2=2-2.9; Grade 3= <2. Lipase (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= >5. BUN/urea (*ULN): Grade 1=1.25-<2.6; Grade 2=2.6-<5.1; Grade 3=5.1-10; Grade 4= >10. Chloride, high (mEq/L): Grade 1=113-<117; Grade 2=117-<121; Grade 3=121-125; Grade 4= >125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-<3; Grade 3=2-<2.5; Grade 4=<2. Potassium, high (mEq/L): : Grade 1= 5.6-<6.1; Grade 2=6.1-<6.6; Grade 3=6.6-7; Grade 4= >7. Sodium, high (mEq/L): Grade 1=146<151; Grade 2=151-<155; Grade 3=155-<160; Grade 4= >=160.
  • The proportion of subjects with serum ALT ≤ 1 times the upper limit of normal [ Time Frame: At Week 48 ]
  • 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 ]
Not Provided
Not Provided
 
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus 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 was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Chronic Hepatitis B Virus, Pediatric
  • Drug: Entecavir
    Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response
    Other Names:
    • Baraclude
    • BMS-200475
  • Drug: Placebo
    Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response
  • Active Comparator: Entecavir
    Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
    Intervention: Drug: Entecavir
  • Placebo Comparator: Placebo
    Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
    Intervention: Drug: Placebo
Jonas MM, Chang MH, Sokal E, Schwarz KB, Kelly D, Kim KM, Ling SC, Rosenthal P, Oraseanu D, Reynolds L, Thiry A, Ackerman P. Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B. Hepatology. 2016 Feb;63(2):377-87. doi: 10.1002/hep.28015. Epub 2015 Oct 16. Erratum in: Hepatology. 2017 Apr;65(4):1427.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
March 31, 2018
March 31, 2013   (Final data collection date for primary outcome measure)

Key Inclusion Criteria

  • Males and females, aged 2 to <18 years
  • Hepatitis B surface antigen-positive
  • Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies
  • Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
  • Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and >100,000 copies/mL at screening

Key Exclusion Criteria

  • Any prior therapy with entecavir
  • At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
  • Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
  • Coinfection with HIV, hepatitis C virus, or hepatitis D virus
  • Decompensated liver disease
  • Liver transplant recipients
  • Other forms of acute and chronic conditions which may cause increased ALT levels
  • Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Canada,   Germany,   Greece,   India,   Israel,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Taiwan,   United Kingdom,   United States
Brazil
 
NCT01079806
AI463-189 ST
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2017

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