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Report for Clinical Trial NCT01705704
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
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.
NCT01705704 Hepatitis B, Chronic MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis
HPO:Hepatitis
Primary Outcomes
Measure: Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatment
Measure: Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatment
Secondary Outcomes
Measure: IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B Time: Samples up to 72 weeks of treatment
Measure: Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatment
Time Perspective: Retrospective
Primary Outcomes
Measure: Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatmentMeasure: Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatment
Secondary Outcomes
Measure: IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B Time: Samples up to 72 weeks of treatmentMeasure: Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine Time: Samples up to 72 weeks of treatment
Cohort
There is one SNP
SNPs
1 rs12356193
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..
Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine.