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Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM (CINAM)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ribavirine
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring drug monitoring, ribavirin-pharmacokinetic, pharmacodynamics, chronic hepatitis C, non 2 non 3 genotype

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients >18 years of age and <65 years of age Génotype non2 non3 Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (Metavir >A1and >F1) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug Exclusion Criteria: Women with ongoing pregnancy or breast feeding IFN or ribavirin therapy at any previous time Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) Serum creatinine level >1.5 times the upper limit of normal at screening History of severe psychiatric disease, especially depression

Sites / Locations

  • Service d'Hépato-gastroentérologie
  • Service d'Hépatogastroentérologie

Outcomes

Primary Outcome Measures

-Study of the complete pharmacokinetics of ribavirin at day 1, and day 84 (week 12).
-Study of the complete pharmacokinetics of amantadin and ribavirin at week 12 + one day and at week 24

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
October 30, 2007
Sponsor
University Hospital, Limoges
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00199719
Brief Title
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM
Acronym
CINAM
Official Title
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C Non 2 -3 Genotype naïve Patients Treated With a 12 Weeks Bitherapy of Peginterferon Alpha 2a-Ribavirin, and Followed by a Tritherapy of Peginterferon Alpha 2a-Ribavirin-Amantadine for 36 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50 % of the patients remain relapsers or virological non responders. The main predictive factors of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological properties, particularly those of ribavirin requires complementary studies. This drug has a large distribution volume and its concentrations display large inter-individual variability. Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on BW and a single ribavirin time point serum concentration at steady state. The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient
Detailed Description
The study is conducted in naive patients infected with genotype non 2 non 3 administered peginterferon alpha 2-a (40KD) weekly, and ribavirin with dose adjusted on BW (< 75 kg 1000 mg/day, >75 kg 1200 mg/day) for the first three months with adjunction of amantadine 200 mg daily for the following 9 months. Plasma concentration profiles of ribavirin were studied after the first dose (D0) and at W12. At each period, blood samples were collected pre-dose and 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosing. Ribavirin concentrations were measured using liquid chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves (AUC0-10h) were derived from plasma concentrations profiles using the linear trapezoidal rule. Virological follow-up was performed at W2, W4, W6, W8, W12, W24 and W72. Early virological response was defined by undetectable viral load at W12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
drug monitoring, ribavirin-pharmacokinetic, pharmacodynamics, chronic hepatitis C, non 2 non 3 genotype

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ribavirine
Primary Outcome Measure Information:
Title
-Study of the complete pharmacokinetics of ribavirin at day 1, and day 84 (week 12).
Title
-Study of the complete pharmacokinetics of amantadin and ribavirin at week 12 + one day and at week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients >18 years of age and <65 years of age Génotype non2 non3 Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (Metavir >A1and >F1) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug Exclusion Criteria: Women with ongoing pregnancy or breast feeding IFN or ribavirin therapy at any previous time Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) Serum creatinine level >1.5 times the upper limit of normal at screening History of severe psychiatric disease, especially depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique LOUSTAUD-RATTI, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépato-gastroentérologie
City
Angers
Country
France
Facility Name
Service d'Hépatogastroentérologie
City
Limoges
Country
France

12. IPD Sharing Statement

Learn more about this trial

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

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