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Completed

NCT Number: NCT02881034

Ribavirin Bioavailability After Telaprevir Exposure

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.

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Key information

Conditions

Hepatitis C Anemia Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hematologic Diseases Hemic and Lymphatic Diseases Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de la Croix Rousse

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

triple therapy

Drug

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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).

  2. Ribavirin plasma trough concentration at week 8 of therapy

    Time frame: at the later phase of therapy (Week 8 ± 2 weeks)

  3. Ribavirin plasma trough concentration after telaprevir withdrawal

    Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))

  4. Renal function at week 8 of therapy

    Time frame: at the later phase of therapy (Week 8 ± 2 weeks)

  5. Renal function after telaprevir withdrawal

    Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2016
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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