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

NCT00199719 | Completed Phase 2

• 1 other identifier: I02022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Hepatitis C

Keywords

drug monitoring; ribavirin-pharmacokinetic; pharmacodynamics; chronic hepatitis C; non 2 non 3 genotype

Outcome Measures

Primary Outcomes (2)

• -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

Interventions

Ribavirine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Hoffmann-La Roche: collaborator

Study Sites (2)

Service d'Hépato-gastroentérologie

Angers, France

Location

Service d'Hépatogastroentérologie

Limoges, France

Location

Related Publications (1)

• Loustaud-Ratti V, Alain S, Rousseau A, Hubert IF, Sauvage FL, Marquet P, Denis F, Lunel F, Cales P, Lefebvre A, Fauchais AL, Liozon E, Vidal E. Ribavirin exposure after the first dose is predictive of sustained virological response in chronic hepatitis C. Hepatology. 2008 May;47(5):1453-61. doi: 10.1002/hep.22217.

  PMID: 18435468 RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Véronique LOUSTAUD-RATTI, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2003
• Study Completion: September 1, 2006
• Last Updated: July 30, 2025

Record last verified: 2007-06

Locations

FR (2)