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

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ClinicalTrials.gov Identifier: NCT01705704
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease
Hepatitis B, Chronic

Study Design
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Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stored serum samples obtained from patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705704


Locations
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Australia, Queensland
Herston, Queensland, Australia, 4006
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
France
Clichy, France, 92118
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Italy
Brescia, Lombardia, Italy, 25123
Bari, Puglia, Italy, 70124
Cagliari, Sardegna, Italy, 09042
Pisa, Toscana, Italy, 56124
Korea, Republic of
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01705704    
Other Study ID Numbers: BV28333
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic