The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
671
1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
1.5 mcg/kg S.C. QW for 24 weeks
1.5 mcg/kg S.C. QW for 48 weeks
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
Time frame: 24 weeks after end of treatment (EOT)
Number of Participants With HBeAg Loss
HBeAg Loss was tested by assay of Abbott MEIA
Time frame: Up to Treatment Week 48
HBe Seroconversion
HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
Time frame: End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Time frame: End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA < 200 IU/mL
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Time frame: End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA Undetectable
Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR).
Time frame: End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Biochemical Response
Biochemical response was defined as alanine aminotransferase (ALT) normalization.
Time frame: End of treatment (EOT) and 24 weeks after EOT
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Number of Participants With Combined Response
Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
Time frame: End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBsAg) Loss
HBsAg Loss was tested by assay of Abbott MEIA
Time frame: End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBs) Seroconversion
HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
Time frame: End of treatment (EOT) and 24 weeks after EOT
Change From Baseline in Liver Biopsy Score
Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked \[involvement of \>2/3 of lobules or nodules\]). Score III (portal inflammation): 0 (none) to 4 (Marked \[dense packing of inflammatory cells in \>2/3 of portal tracts\]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis).
Time frame: Baseline to 24 weeks after end of treatment