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

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01705704
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-12
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine	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	Samples up to 72 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B	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	Samples up to 72 weeks of treatment