Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
|Hepatitis D, Chronic Hepatitis B, Chronic||Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection|
- Number of Participants With a Virological Response [ Time Frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation ]For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
- Number of Participants With a Biochemical Response [ Time Frame: 52 weeks (EOT), 104 weeks (EOF) ]A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
- Number of Participants With a Combined Response [ Time Frame: 52 weeks (EOT), 104 weeks (EOF) ]
The combined response was defined as an ALT level below the upper
reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.
- Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) [ Time Frame: 52 week (EOT) ]Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.
- Number of Participants With a Liver Histology Response [ Time Frame: Baseline and 52 week (EOT) ]
The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.
The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT.
|Study Start Date:||December 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight.
Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)
Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
Other Name: SCH 54031, PegIntron