|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|
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.
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