CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg +2 moredrug
Likely dose
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcgfrom 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.

Search/NCT01095835
NCT01095835Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Controlled Study Comparing the Efficacy and Safety of 48 Weeks of 40kD Branched Pegylated Interferon Alfa-2a (PEG-IFN, RO 25-8310) Versus 96 Weeks of PEG-IFN, Alone or in Combination With 100 mg Lamivudine for 48 Weeks in Patients With HBeAg-Negative Chronic Hepatitis B

Hoffmann-La Roche·interventional·Posted Mar 30, 2010·Updated Nov 3, 2016

In Brief

A Phase 3 clinical trial evaluating Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg, Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg, and 1 other intervention for Hepatitis B, Chronic. Completed, enrolled 131 participants across 22 sites.

Detailed Summary

This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2010
Enrollment StartFeb 1, 2005
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.3 years ago

Interventions

Pegylated interferon (PEG-IFN) alfa-2a, 180 mcgdrug

PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.

Pegylated interferon (PEG-IFN) alfa-2a, 135 mcgdrug

PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.

Lamivudine (LAM)drug

Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.