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

Hepatitis B, Chronic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705704
• Other study ID #: BV28333
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: November 1, 2016
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: CENTER FOR PROPHYLAXIS & CONTROL OF AIDS & OTHER INFECTIONS
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  France,  Hong Kong,  Italy,  Korea, Republic of,  New Zealand,  Russian Federation,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No