Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks
Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Guiyang, Guizhou, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanchang, Jiangxi, China
Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing
HBV DNA Level \<50 IU/mL=approximately 300 copies/mL.
Time frame: At Week 12 from Day 1
Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing
HBV=hepatitis B virus. HBV DNA Level \<50 IU/mL=approximately 300 copies/mL.
Time frame: At Week 48 from Day 1
Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing
HBV=hepatitis B virus
Time frame: At Weeks 12 and 48 from Day 1
Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)
ULN=upper limit of normal. ALT normalization= ≤1\*ULN, among participants with baseline ALT \>1\*ULN
Time frame: At Weeks 12 and 48 from Day 1
Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion
Time frame: At Weeks 12 and 48 from Day 1
Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion
Time frame: At Weeks 12 and 48 from Day 1
Number of Participants With Genotypic Resistance to Entecavir
Time frame: At Week 48 from Day 1
Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution
Changchun, Jilin, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
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. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.
Time frame: Continually from Day 1 through Week 48, and through 24-week follow-up period
Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results
Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.
Time frame: Day 1 through Week 48