Treatment Insulin Resistence in HCV G-1 Patient

Chronic Hepatitis C Clinical Trial

— TRIC-1  

Official title:

Effect of Treatment of Insulin Resistance in Patients With Chronic Hepatitis C Genotype 1 Treated With Peginterferon Alfa-2a in Combination With Ribavirin in Current Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546442
• Other study ID #: 2005-02446-19
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2007
• Last updated: October 17, 2007
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2007
• Source: Valme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Insulin Resistance

Intervention

Drug:
• Metformine
850-2550 mg/daily for 48 weeks

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

Locations

Country	Name	City	State
Spain	Fundación Hospital de Alcorcón	Alcorcón	Madrid
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Clínico Universitario San Cecilio	Granada
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital de Leon	Leon
Spain	Hospital Carlos III	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	Hospital de Donostia	San Sebastian	Guipuzcoa
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital General Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Valme University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with HCV-RNA		Week 72
Secondary	Percentage of patients who has erradicated the insulin resistance		week 72