Treatment Insulin Resistence in HCV G-1 Patient (TRIC-1)

October 17, 2007 updated by: Valme University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Ciudad Real, Spain, 13005
        • Hospital General de Ciudad Real
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Granada, Spain, 18003
        • Hospital Clinico Universitario San Cecilio
      • Granada, Spain, 18004
        • Hospital Virgen de las Nieves
      • Leon, Spain, 24071
        • Hospital de Leon
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28029
        • Hospital Carlos III
      • Madrid, Spain, 28035
        • Hospital Puerta de Hierro
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41014
        • Hospital Universitario de Valme
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Valencia, Spain, 46014
        • Hospital General Universitario
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Hospital de Donostia
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo of metformine 850-2550 mg/daily for 48 weeks
Other: Placebo of metformine
850-2550 mg/daily for 48 weeks
Experimental: 1
Metformine 850-2550 mg/daily for 48 weeks
Drug: Metformine
850-2550 mg/daily for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with HCV-RNA
Time Frame: Week 72
Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who has erradicated the insulin resistance
Time Frame: week 72
week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valme University Hospital

Investigators

  • Study Director: Manuel Romero-Gomez, Dr, Hospital Universitario de Valme. Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 19, 2007

Last Update Submitted That Met QC Criteria

October 17, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-02446-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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