At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 76 enrolled

Drug / intervention

Pegylated Interferon (Peginterferon) Alfa-2a +1 moredrug

Likely dose

Pegylated Interferon (Peginterferon) 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/NCT01706575

NCT01706575Phase 2Completed

Compare CT.gov

A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks PEG-Interferon Alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment With Nucleos(t)Ide Analogues (NAs), Showing Stable HBV DNA Suppression

Hoffmann-La Roche·interventional·Posted Oct 15, 2012·Updated Feb 20, 2017

In Brief

A Phase 2 clinical trial evaluating Pegylated Interferon (Peginterferon) Alfa-2a and Nucleos(t)ide Analogues (NA) for Hepatitis B, Chronic. Completed, enrolled 76 participants across 27 sites.

Detailed Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis B, Chronic

CountriesItaly

Collaborators--

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedOct 2012

Enrollment StartJan 2013

Primary CompletionSep 2013

Study CompletionNov 2014

TodayJul 2026

First PostedOct 15, 2012

Enrollment StartJan 1, 2013

Primary CompletionSep 1, 2013

Study CompletionNov 1, 2014

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 13.7 years ago

Interventions

Pegylated Interferon (Peginterferon) Alfa-2adrug

Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.

Nucleos(t)ide Analogues (NA)drug

Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.