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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01705704
Other study ID # BV28333
Secondary ID
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


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
See also
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