RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00485342

Purpose

The aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2 and ribavirin) in naïve patients with chronic hepatitis C of genotype 1 or 4: “reference” strategy corresponding to standards of care recommended by the French consensus conference versus Test strategy which associate therapeutical drug monitoring of ribavirin with potential adaptation of ribavirin dosage and the co-prescription of epoetin beta in case of secondary anaemia.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: ribavirin adjusted dose	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Pragmatic, Multicentric, Controlled and Randomised Clinical Trial Investigating in Open the Efficacy and Safety of Dose Adaptation of Ribavirin Using Therapeutic Drug Monitoring During Combination Peginterferon Alfa-2 and Ribavirin Treatment in Naive Patients With Chronic Hepatitis C of Genotype 1 or 4, and Presenting With a Slow Kinetics of Virological Response on a First Combination Therapy.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Comparison of sustained virological response rates = proportion of subjects with a negative PCR HCV-RNA test at Week 72

Secondary Outcome Measures:

Proportion of patients reaching the target concentration of ribavirin Rapid virologic response Early virologic response End of treatment response Relapse rate Clinical adverse events Laboratory test abnormalities Haemoglobin level changes

Estimated Enrollment:	198
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

65 years >Age  18 years
Chronic hepatitis C documented by PCR diagnosis with Metavir score > F1 at liver biopsy (< 18 months) or actitest/fibrotest and/or fibroscan (< 3 months)
Genotype HCV-1 or -4
Compensated liver disease (Child-Pugh  6)
Naive patients
High HCV viral load (> 800 000 IU/mL)
Patient for who the physician decided to initiate a combination treatment of chronic hepatitis C with pegylated interferon alfa-2 plus ribavirin
Negative HBsAg test and HIV-RNA test
Negative pregnancy test at baseline in women and efficient contraception all along the treatment period, and up to 7 months after discontinuation for women and men

Exclusion Criteria:

non HCV liver disease
Organ transplant whatever the organ
Clinical or radiological evidence of liver carcinoma (echography, CT scan, MRI)
Severe psychiatric disorder
Non compensated thyroid dysfunction
Woman pregnant or breast-feeding
Recent history of epilepsy
Absolute contraindications to one of the drug of combination therapy
Biological abnormalities at pre-treatment check-up, such as: Neutropenia (<1500/mm³); Thrombopenia (< 90 000/mm³); Thrombocytosis (>500 000/mm³ soit 500 G/L); Haemoglobinemia (<13 g/dl for men et <12 g/dl for women)
Renal insufficiency (serum creatinine level >130 µmol/L)
Iron deficiency (CST<20%)
Allergy to epoetin or one of the components
Treatment by epoetin within 2 months prior inclusion
Chronic cardiac failure (grade III or IV - NYHA)
Partially controlled hypertension
Major surgery within the previous 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485342

Contacts

Contact: Marianne Maynard, MD

33 4 72 41 30 88

marianne.maynard-muet@chu-lyon .fr

Locations

France
Marianne Maynard	Recruiting
Lyon, France, 69002
Contact: Marianne Maynard, MD 33 4 72 41 30 88 marianne.maynard-muet@chu-lyon.fr
Principal Investigator: Christian Trépo, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Christian Trépo, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2005-400
Study First Received:	June 8, 2007
Last Updated:	June 8, 2007
ClinicalTrials.gov Identifier:	NCT00485342
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Chronic hepatitis C
Genotype 1 or 4
Naïf
bitherapy
drug monitoring

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009