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Trial record 33 of 131 for:    "Hepatitis" | "Lamivudine"

A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

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ClinicalTrials.gov Identifier: NCT00393484
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : November 18, 2010
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 26, 2006
First Posted Date  ICMJE October 27, 2006
Results First Submitted Date  ICMJE October 21, 2010
Results First Posted Date  ICMJE November 18, 2010
Last Update Posted Date November 26, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
Percentage of Participants Who Achieved a Virologic Response at Week 24 [ Time Frame: At Week 24 ]
Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
Compare the proportion of subjects who achieve a virologic response at Week 24 between the ETV and LVD treatment groups
Change History Complete list of historical versions of study NCT00393484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
  • Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96 [ Time Frame: At Weeks 24, 48, and 96 ]
    The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.
  • Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240 [ Time Frame: At Weeks 24, 48, 96, 144, 192, and 240 ]
    Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.
  • Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24 [ Time Frame: At Week 24 ]
    Mean ALT values from baseline by laboratory test. .
  • Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96 [ Time Frame: At Weeks 24, 48, and 96 ]
    Normalization of serum ALT= ≤*institutional upper limit of normal.
  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24 [ Time Frame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period ]
    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. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
  • Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24 [ Time Frame: Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period ]
    ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
  • Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24 [ Time Frame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period ]
    ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
  • Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24 [ Time Frame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period ]
    Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.
  • Number of Participants With Virologic Rebound at Week 24 [ Time Frame: At Week 24 ]
    Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).
  • Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240 [ Time Frame: At Weeks 48, 96, 144, 192, and 240 ]
    Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay
  • Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96 [ Time Frame: At 96 weeks ]
    Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).
  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240 [ Time Frame: Start of dosing (Day 1) until end of treatment (Week 240) + 5 days ]
    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.
  • Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96 [ Time Frame: Start of dosing (Day 1) until Week 96 ]
    ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2006)
  • Mean log10 reduction from baseline in HBV DNA
  • Proportion of subjects with normalization of serum ALT (≤ 1 x ULN)
  • Proportion of subjects with HBV DNA < 103, <104 or < 105 copies/mL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Official Title  ICMJE A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea
Brief Summary Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE
  • Drug: Entecavir
    Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
    Other Names:
    • Baraclude
    • BMS-200475
  • Drug: Lamivudine Placebo
    Capsules, Oral, 0 mg, once daily (0-96 weeks)
  • Drug: Lamivudine

    Capsules, Oral, 100 mg, once daily (0-96 weeks)

    Tablets, Oral, 100 mg, once daily (96-240 weeks)

  • Drug: Entecavir Placebo
    Tablets, Oral, 0 mg, once daily (0-96 weeks)
Study Arms  ICMJE
  • Experimental: Arm A

    Entecavir + Lamivudine placebo (0-96 weeks)

    Entecavir (96-240 weeks)

    Interventions:
    • Drug: Entecavir
    • Drug: Lamivudine Placebo
  • Active Comparator: Arm B

    Lamivudine + Entecavir placebo (0-96 weeks)

    Lamivudine (96-240 weeks)

    Interventions:
    • Drug: Lamivudine
    • Drug: Entecavir Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2010)
122
Original Enrollment  ICMJE
 (submitted: October 26, 2006)
120
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nucleoside and nucleotide-naive subjects with chronic HBV infection
  • Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
  • Detectable HBsAg
  • HBV DNA ≥ 105 copies/mL by PCR
  • ALT 1.3 to 10 x the ULN
  • HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393484
Other Study ID Numbers  ICMJE AI463-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2014

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