Treatment Insulin Resistence in HCV G-1 Patient

NCT ID: NCT00546442

Last Updated: 2007-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-01-31

Brief Summary

To evaluate the effect of treatment of insulin resistance in the response of chronic hepatitis C treatment, mesure as HCV-RNA negative at week 72.

4.3.2 Objetivos secundarios To evaluate the efficacy and safety of treatment with metformine to erradicate the insulin resistance of patients with chornic hepatitis C genotype 1 measure as HOMA-IR < 2.

Detailed Description

Differents studies show that infection by virus hepatitis C have a relevant rol in the development of insulin resistance. The insulin resistence is associated with a progression of fibrosis and the development of steatosis. The insulin resistence is frecuently associated with very difficult to cure patients as cirrhotics, afro-american patients, overweight patients and co-infected HCV-HIV patients. Recently is repported that sustained virological (SVR) response in genotype 1 patients is different according the insulin resistance. The SVR was 60% in patients without insulin resistance versus 20% in patients with strong insulin resistance (HOMA > 4.

The present trial desire to analyze the effect that the treatment of insulin resistance produce in higher range of RVS.

Conditions

Chronic Hepatitis C

Keywords

insulin resistance; chronic hepatitis C; genotype 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2

Placebo of metformine 850-2550 mg/daily for 48 weeks

Group Type: PLACEBO_COMPARATOR

Placebo of metformine

Intervention Type: OTHER

850-2550 mg/daily for 48 weeks

1

Metformine 850-2550 mg/daily for 48 weeks

Group Type: EXPERIMENTAL

Metformine

Intervention Type: DRUG

850-2550 mg/daily for 48 weeks

Interventions

Metformine

850-2550 mg/daily for 48 weeks

Intervention Type: DRUG

Placebo of metformine

850-2550 mg/daily for 48 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female patients with 18 years of age or more
• Serum HCV-RNA quantifiable
• Genotype 1
• Liver disease compensated
• HOMA-IR > 2
• Treatment with Peginterferon alfa-2a + Ribavirin.
• Negative urine or blood pregnancy test (for women of childbearing potential)
• All fertile males and females must be using effective contraception

Exclusion Criteria

• Liver chirrosis
• Diabetes
• Women with ongoing pregnancy or breast feeding
• HIV positive
• Patients who during 6 months previous to treatment loss more of 10% of weight
• Therapy with anti-neoplasic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
• Any investigational drug 6 weeks prior to the first dose of study drug
• History or other evidence of a medical condition associated with chronic liver disease other than HCV
• Carcinoma hepatocellular
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
• Hgb <12 g/dL in women or <13 g/dL in men or any patient for whom anemia would be medically problematic
• History of significant cardiac disease that could be worsened by acute anemia
• Serum creatinine level >1.5 times the upper limit of normal at screening
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• History of a severe seizure disorder or current anticonvulsant use
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
• Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
• Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
• Inability or unwillingness to provide informed consent or abide by the requirements of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valme University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Manuel Romero-Gomez, Dr

Role: STUDY_DIRECTOR

Hospital Universitario de Valme. Sevilla

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Hospital General de Ciudad Real

Ciudad Real, Ciudad Real, Spain

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Hospital Clínico Universitario San Cecilio

Granada, Granada, Spain

Hospital Virgen de las Nieves

Granada, Granada, Spain

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital de Leon

León, Leon, Spain

Fundación Hospital de Alcorcón

Alcorcón, Madrid, Spain

Hospital de la Princesa

Madrid, Madrid, Spain

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Hospital Carlos III

Madrid, Madrid, Spain

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Hospital La Paz

Madrid, Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Virgen Macarena

Seville, Sevilla, Spain

Hospital Universitario de Valme

Seville, Sevilla, Spain

Hospital General Universitario

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

2005-02446-19

Identifier Type: -

Identifier Source: org_study_id