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

Roche

Status: Completed

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01705704

BV28333

Details and patient eligibility

About

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.

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

269 participants in 1 patient group

Cohort