This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
0.5mg po daily for 8 weeks
0.5mg po daily for 48 weeks
180 micrograms sc/week for 48 weeks
Unnamed facility
Changsha, China
Unnamed facility
Chengdu, China
Unnamed facility
Fuzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Wuhan, China
Unnamed facility
Xi'an, China
Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48
Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).
Time frame: At Week 48
Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48
Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.
Time frame: At Week 48
Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48
Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA \< 1000 copies/mL was reported.
Time frame: At Week 48
Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48
Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.
Time frame: At Week 48
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48
Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)
Time frame: At Week 48
Percentage of Participants With Normalized Alanine Aminotransferase at Week 48
Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value \> upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.
Time frame: At Week 48
Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time
Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.
Time frame: Up to Week 48
Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time
Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. \<1000 was replaced by 1000 and \<0.2 was replaced by 0.2. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.
Time frame: Up to Week 48
Number of Participants With Incidence of Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Week 48
Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event
Participants with clinically significant laboratory abnormalities which were captured as an AE (at the \>=5% threshold) were presented.
Time frame: Up to Week 48
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