At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 18 enrolled
Drug / intervention
peginterferon alfa-2a [Pegasys]drug
Likely dose
peginterferon alfa-2a [Pegasys] 180 microgramsfrom 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.
PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
In Brief
A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] for Hepatitis B, Chronic. Completed, enrolled 18 participants across 23 sites.
Detailed Summary
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesRussia
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedJun 2007
Primary CompletionOct 2009
TodayJul 2026
First PostedJun 19, 2007
Enrollment StartAug 1, 2006
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.0 years ago
Interventions
peginterferon alfa-2a [Pegasys]drug
180 micrograms sc weekly for 48 weeks