Clinical trial NCT00546442: Treatment Insulin Resistence in HCV G-1 Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: insulin resistance
chronic hepatitis C
genotype 1
Lead sponsor: Valme University Hospital
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients with HCV-RNA
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of patients who has erradicated the insulin resistance
timeFrame: week 72
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Leon
country: Spain
facility: Hospital de Leon
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario
Study officials:
affiliation: Hospital Universitario de Valme. Sevilla
name: Manuel Romero-Gomez, Dr
role: STUDY_DIRECTOR
References: