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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01716403
First received: October 25, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
C Hepatitis, Tri Therapy
Biological: Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Telaprevir Exposure on the Severe Anemia Induced by Ribavirin/Pegylated Interferon/Telaprevir Tri-therapy in HCV Infected Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • telaprevir concentration and area under the curve [ Time Frame: Day 0, Day 2, week 2, week 4, week 8 and week12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ribavirin concentration and area under the curve [ Time Frame: Day 0, Day 2, week 2, week 4, week 8 and week12 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • viral load [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma


Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HCV tritherapy and anemia
HCV-genotype 1 infected patients
Biological: Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

48 HCV-genotype 1 infected patients (16 naive patients, 16 prior partial responders/relapsers and 16 prior null responders to ribavirin/PEG-INF treatment)

Criteria

Inclusion Criteria:

  • Man or woman older than 18 yr. 2- HCV genotype 1 infection as confirmed by a positive viral load 6 months after the selection visit or confirmed by the mean of a liver biopsy within 1 year before screening for the study.

    3- Patient with one of the following criteria: Patient naive of any treatment against HCV infection Or Prior null responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks and whom HCV viral load decline was <2 log at week 12 Or Prior partial responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks, who never had a negative viral load while the viral load decline was >2 log at week 12 Or Prior relapser patient: patient previously treated by ribavirin/PEG-INF for 48 weeks, with a negative viral load at the end of treatment and a positive viral load 6 months later 4- Patient who has stopped his treatment for at least 12 weeks 5- Patient who had a liver biopsy or a Fibroscan within the 24 months before the start of the study with a Metavir fibrosis score F ≥ 3.

    6- Patient who fulfills criteria for telaprevir treatment as defined by the licence 7- Patients who accepts to use 2 contraceptive methods until 6 months after the end of the treatment 8- Patient who had given his written informed consent 10- Patient insured under the french social security system

Exclusion Criteria:

1- Infection/co-infection by HCV genotype different than genotype 1 2- Patient with a medical contraindication to PEG-INF or ribavirin 3- Patient with history of allergy or intolerance to telaprevir 4- Patient using contraindicated drugs 5- Patient with history of decompensated liver disease and/or presenting biochemical measurements as follows at the inclusion visit:

  • International Normalized Ratio (INR) > 1,5
  • Albumin <3,3 g/dl
  • Total bilirubin>1,8 N apart for patient with Gilbert syndrome 6- Liver disease from other causes 7- Patient with hepatocellular carcinoma or history of cancer 8- Patient with a history of graft transplantation and treated by immunosuppressive drugs 9- Patient who are regularly treated by corticosteroids 11- Patient with hemophilia or coagulation troubles 12- HIV or HBV co-infection 14- Patient with body mass index> 30 kg/m2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716403

Contacts
Contact: Francoise Stanke, PharmD, PhD FStanke@chu-grenoble.fr

Locations
France
Grenoble University Hospital Recruiting
Grenoble, France, 38043
Contact: Francoise Stanke, PharmD, PhD       FStanke@chu-grenoble.fr   
Principal Investigator: Jean-Pierre Zarski, MD, PhD         
Sub-Investigator: Vincent Leroy, MD, PhD         
Sub-Investigator: Marie-Noelle Hilleret, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Pierre Zarski, MD, PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01716403     History of Changes
Other Study ID Numbers: 1211
Study First Received: October 25, 2012
Last Updated: January 25, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
C hepatitis, telaprevir concentration, ribavirin oncentration, anemia

Additional relevant MeSH terms:
Hepatitis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2014