A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

November 1, 2016 updated by: Hoffmann-La Roche

An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

269

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

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
  • France
      • Clichy, France, 92118
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
    • Puglia
      • Bari, Puglia, Italy, 70124
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
    • Toscana
      • Pisa, Toscana, Italy, 56124
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 120-752
  • New Zealand
      • Auckland, New Zealand, 100
      • Hamilton, New Zealand
  • Russian Federation
      • Samara, Russian Federation, 443011
      • St Petersburg, Russian Federation, 190103
      • Stavropol, Russian Federation, 355017
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 228510
  • Taiwan
      • Kaohsiung, Taiwan, 807
      • Taipei, Taiwan, 100
      • Taoyuan, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50202
      • Khon Kaen, Thailand, 40002
      • Songkhla, Thailand, 90112

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

Sampling Method

Probability Sample

Study Population

Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.

Description

Inclusion Criteria:

  • Patients with HBe-antigen positive or negative chronic hepatitis B, and no other chronic viral infections who completed therapy for Hepatitis B with Pegasys ± lamivudine
  • Inclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432
  • Samples from patients treated with either Pegasys or Pegays + lamivudine are included in this analytical study
  • Samples will only be analyzed for patients where Investigational Review Board approval has been granted

Exclusion Criteria:

  • Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Time Frame: Samples up to 72 weeks of treatment
Samples up to 72 weeks of treatment
Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Time Frame: Samples up to 72 weeks of treatment
Samples up to 72 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B
Time Frame: Samples up to 72 weeks of treatment
Samples up to 72 weeks of treatment
Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine
Time Frame: Samples up to 72 weeks of treatment
Samples up to 72 weeks of treatment

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BV28333

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.

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