At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 68 enrolled
Drug / intervention
Peginterferon alfa-2b (PegIntron, SCH 54031)biological
Likely dose
Peginterferon alfa-2b (PegIntron, SCH 54031) 1.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection
In Brief
A Phase 3 clinical trial evaluating Peginterferon alfa-2b (PegIntron, SCH 54031) for Hepatitis D, Chronic and Hepatitis B, Chronic. Completed, enrolled 68 participants.
Detailed Summary
The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis D, Chronic, Hepatitis B, Chronic
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedMay 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedMay 30, 2008
Enrollment StartDec 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.1 years ago
Interventions
Peginterferon alfa-2b (PegIntron, SCH 54031)biological
Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.