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Telaprevir Exposure and Severe Anemia in HCV Infected Patients Treated by Tri-therapy

NCT01716403 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2017-01-13

No results posted yet for this study

Summary

The risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. The trough concentration or AUC of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve tolerance and SVR.

Conditions

  • C Hepatitis, Tri Therapy

Interventions

BIOLOGICAL

Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Pierre Zarski, MD, PhD · University Hospital, Grenoble

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716403 on ClinicalTrials.gov