Completed

Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study

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What is being tested

Interleukin 28B testing

Other
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 8, 2012

Actual date on which the first participant was enrolled.

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.

NCT01697501
Principal SponsorHoffmann-La Roche
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsDisease AttributesHepatitis B, Chronic

Criteria

Inclusion Criteria: Adult patients, >/= 18 years of age Chronic hepatitis B Previous participation in study ML18253 Administration of at least one dose of the study drug during ML18253 study Exclusion Criteria: Patients not satisfying the above inclusion criteria will not be enrolled in the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

Bari, ItalyOpen Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive in Google Maps

Ospedale de Bellis; Reparto Medicina Generale

Castellana Grotte, Italy

Az. Osp. S. Sebastiano; Divisione Malattie Infettive

Caserta, Italy

Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia

Naples, Italy
Completed12 Study Centers