Ribavirin Bioavailability After Telaprevir Exposure

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Triple therapy

• Registration Number: NCT02881034
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Patients with hepatitis C virus infection
• Previous non-response to pegylated-interferon/ribavirin therapy
• Re-treatment with pegylated-interferon/ribavirin and telaprevir

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Exclusion Criteria

• Decompensated liver cirrhosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis C patients	Triple therapy	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

Primary Outcome Measures

Name	Time	Method
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy	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	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

Secondary Outcome Measures

Name	Time	Method
Ribavirin plasma trough concentration at week 8 of therapy	at the later phase of therapy (Week 8 ± 2 weeks)
Change in renal function between baseline and week 4 of triple therapy	Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of 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).
Ribavirin plasma trough concentration after telaprevir withdrawal	after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Renal function at week 8 of therapy	at the later phase of therapy (Week 8 ± 2 weeks)
Renal function after telaprevir withdrawal	after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France