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Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

NCT01524679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2020-02-18

Study results available
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Summary

A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks.

170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.

Conditions

Interventions

DRUG

Pegylated interferon alfa-2a plus nucleos(t)ide(s)

Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Peter R. Galle, Univ.-Prof. Dr. med. · I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-08-28
Completion
2017-08-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524679 on ClinicalTrials.gov