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

NCT ID: NCT01705704

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

269 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Herston, Queensland, Australia

Site Status

Fitzroy, Victoria, Australia

Site Status

Clichy, , France

Site Status

Hong Kong, , Hong Kong

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Hong Kong, , Hong Kong

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Bari, Apulia, Italy

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Brescia, Lombardy, Italy

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Cagliari, Sardinia, Italy

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Pisa, Tuscany, Italy

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Auckland, , New Zealand

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Hamilton, , New Zealand

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Saint Petersburg, , Russia

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Samara, , Russia

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Stavropol, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

Site Status

Chiang Mai, , Thailand

Site Status

Khon Kaen, , Thailand

Site Status

Songkhla, , Thailand

Site Status

Countries

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Australia France Hong Kong Italy New Zealand Russia Singapore South Korea Taiwan Thailand

References

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van Bommel F, van Bommel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Bohm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.

Reference Type DERIVED
PMID: 29741634 (View on PubMed)

Other Identifiers

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BV28333

Identifier Type: -

Identifier Source: org_study_id