Clinical trial NCT00393484: A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 122
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved a Virologic Response at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: 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
timeFrame: At Weeks 24, 48, and 96
measure: Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240
timeFrame: At Weeks 24, 48, 96, 144, 192, and 240
measure: Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24
timeFrame: At Week 24
measure: Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96
timeFrame: At Weeks 24, 48, and 96
measure: 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
timeFrame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
measure: 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
timeFrame: Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
measure: Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24
timeFrame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period
measure: Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24
timeFrame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
measure: Number of Participants With Virologic Rebound at Week 24
timeFrame: At Week 24
measure: Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240
timeFrame: At Weeks 48, 96, 144, 192, and 240
measure: Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96
timeFrame: At 96 weeks
measure: 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
timeFrame: Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
measure: Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96
timeFrame: Start of dosing (Day 1) until Week 96
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Chuncheon
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Guri
country: Korea, Republic of
facility: Local Institution
city: Jeonju
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: