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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
Capsules, Oral, 0 mg, once daily (0-96 weeks)
Capsules, Oral, 100 mg, once daily (0-96 weeks) Tablets, Oral, 100 mg, once daily (96-240 weeks)
Local Institution
Bucheon-si, South Korea
Local Institution
Busan, South Korea
Local Institution
Chuncheon, South Korea
Percentage of Participants Who Achieved a Virologic Response at Week 24
Virologic response=Hepatitis B virus DNA \<300 copies/mL by polymerase chain reaction assay.
Time frame: At Week 24
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
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.
Time frame: At Weeks 24, 48, and 96
Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA 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.
Time frame: At Weeks 24, 48, 96, 144, 192, and 240
Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24
Mean ALT values from baseline by laboratory test. .
Time frame: At Week 24
Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96
Normalization of serum ALT= ≤\*institutional upper limit of normal.
Time frame: At Weeks 24, 48, and 96
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
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Tablets, Oral, 0 mg, once daily (0-96 weeks)
Local Institution
Daegu, South Korea
Local Institution
Daegu, South Korea
Local Institution
Daejeon, South Korea
Local Institution
Guri-si, South Korea
Local Institution
Jeonju, South Korea
Local Institution
Seoul, South Korea
Local Institution
Seoul, South Korea
...and 5 more locations
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.
Time frame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
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
ALT flares=ALT\>2\*Baseline and 10\*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
Time frame: Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24
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).
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
Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24
Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.
Time frame: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
Number of Participants With Virologic Rebound 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).
Time frame: At Week 24
Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240
Undetectable HBV DNA= \<300 copies/mL by polymerase chain reaction assay
Time frame: At Weeks 48, 96, 144, 192, and 240
Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96
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).
Time frame: At 96 weeks
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
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.
Time frame: Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at 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).
Time frame: Start of dosing (Day 1) until Week 96