An observational study in Hepatitis C, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-29.
Sponsored by Hospices Civils de Lyon · Observational
Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 37 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir
Exclusion Criteria:
Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir
Drug: Triple therapy
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification
Time frame: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Change in renal function between baseline and week 4 of triple therapy
Renal function was assessed with the commonly used Modification of the Diet in Renal Disease (MDRD) study equation which allows to assess the estimated glomerular filtration rate (eGFR).
Time frame: Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Ribavirin plasma trough concentration at week 8 of therapy
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Ribavirin plasma trough concentration after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Renal function at week 8 of therapy
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Renal function after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon