Hepatitis B virus infection
Conditions
Brief summary
Safety defined as treatment-emerging adverse events (AEs) = or > grade 3 probably or definitely related to pomalidomide., Safety defined as all other treatment-emerging AEs, graded according to severity and assessed as either not related or possibly, probably or definitely related to pomalidomide
Detailed description
Quantitative plasma levels of HBV DNA, Quantitative plasma levels of HBsAg, Serum titres of anti-HBs and anti-HBe, Levels of the liver function tests (LFTs) including ALT, bilirubin and PP, Numbers, proportions and subset distribution of NK cells including changes in the proportion of cytotoxic and dysfunctional NK cells as determined by expression of CD56, CD16, activating and inhibitory markers using flow cytometry, The frequency of CD4 and/or CD8 T-cell responses to HBV peptides measured either by intracellular cytokine staining (ICS), activation induced marker (AIM) assay or by ELISPOT and the proportion of polyfunctional CD8+ T cells
Interventions
DRUGPomalidomide
Sponsors
Region Midtjylland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety defined as treatment-emerging adverse events (AEs) = or > grade 3 probably or definitely related to pomalidomide., Safety defined as all other treatment-emerging AEs, graded according to severity and assessed as either not related or possibly, probably or definitely related to pomalidomide | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative plasma levels of HBV DNA, Quantitative plasma levels of HBsAg, Serum titres of anti-HBs and anti-HBe, Levels of the liver function tests (LFTs) including ALT, bilirubin and PP, Numbers, proportions and subset distribution of NK cells including changes in the proportion of cytotoxic and dysfunctional NK cells as determined by expression of CD56, CD16, activating and inhibitory markers using flow cytometry, The frequency of CD4 and/or CD8 T-cell responses to HBV peptides measured either by intracellular cytokine staining (ICS), activation induced marker (AIM) assay or by ELISPOT and the proportion of polyfunctional CD8+ T cells | — |
Countries
Denmark
Outcome results
None listed