- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881034
Ribavirin Bioavailability After Telaprevir Exposure
August 26, 2016 updated by: Hospices Civils de Lyon
Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lyon, France
- Hôpital de La Croix Rousse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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
Description
Inclusion Criteria:
- Patients with hepatitis C virus infection
- Previous non-response to pegylated-interferon/ribavirin therapy
- Re-treatment with pegylated-interferon/ribavirin and telaprevir
Exclusion Criteria:
- Decompensated liver cirrhosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hepatitis C patients
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
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
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in renal function between baseline and week 4 of triple therapy
Time Frame: Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
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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).
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Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
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Ribavirin plasma trough concentration at week 8 of therapy
Time Frame: at the later phase of therapy (Week 8 ± 2 weeks)
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at the later phase of therapy (Week 8 ± 2 weeks)
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Ribavirin plasma trough concentration after telaprevir withdrawal
Time Frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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Renal function at week 8 of therapy
Time Frame: at the later phase of therapy (Week 8 ± 2 weeks)
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at the later phase of therapy (Week 8 ± 2 weeks)
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Renal function after telaprevir withdrawal
Time Frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
August 18, 2016
First Submitted That Met QC Criteria
August 25, 2016
First Posted (Estimate)
August 26, 2016
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0557
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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