A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

March 10, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Caserta, Campania, Italy, 81100
        • Az. Osp. S. Sebastiano; Divisione Malattie Infettive
      • Napoli, Campania, Italy, 80131
        • Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
      • Parma, Emilia-Romagna, Italy, 43100
        • Az. Osp. Uni Ria Di Parma; Gastro-Enterology
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
      • Milano, Lombardia, Italy, 20122
        • Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
      • Castellana Grotte, Puglia, Italy, 70013
        • Ospedale de Bellis; Reparto Medicina Generale
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
        • Uni Di Cagliari; Dept. Di Scienze Mediche
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
    • Toscana
      • Pisa, Toscana, Italy, 56124
        • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chronic hepatitis B patients
Other: Interleukin 28B testing
Blood sampling for IL28B genotyping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
Time Frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
Time Frame: EoF
EoF

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
Time Frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96
EoT, as defined in the predecessor study, was at Week 48 or Week 96
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
Time Frame: EoT
EoT
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time Frame: EoT and EoF
EoT and EoF
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time Frame: EoT and EoF
EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time Frame: EoT and EoF
EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time Frame: EoT and EoF
EoT and EoF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2012

Primary Completion (ACTUAL)

June 21, 2013

Study Completion (ACTUAL)

June 21, 2013

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28470
  • 2012-002777-56 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Clinical Trials on Interleukin 28B testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe