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

This study has been completed.
Sponsor:
Information provided by:
Valme University Hospital
ClinicalTrials.gov Identifier:
NCT00546442
First received: October 17, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Metformine
Other: Placebo of metformine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Valme University Hospital:

Primary Outcome Measures:
  • Percentage of patients with HCV-RNA [ Time Frame: Week 72 ]

Secondary Outcome Measures:
  • Percentage of patients who has erradicated the insulin resistance [ Time Frame: week 72 ]

Enrollment: 126
Study Start Date: May 2006
Study Completion Date: January 2007
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546442

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital de Donostia
San Sebastian, Guipuzcoa, Spain, 20014
Fundación Hospital de Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital del Mar
Barcelona, Spain, 08003
Hospital General de Ciudad Real
Ciudad Real, Spain, 13005
Hospital Reina Sofía
Córdoba, Spain, 14004
Hospital Clínico Universitario San Cecilio
Granada, Spain, 18003
Hospital Virgen de las Nieves
Granada, Spain, 18004
Hospital de Leon
Leon, Spain, 24071
Hospital Carlos III
Madrid, Spain, 28029
Hospital La Paz
Madrid, Spain, 28046
Hospital Puerta de Hierro
Madrid, Spain, 28035
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario de Valme
Sevilla, Spain, 41014
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital General Universitario
Valencia, Spain, 46014
Sponsors and Collaborators
Valme University Hospital
Investigators
Study Director: Manuel Romero-Gomez, Dr Hospital Universitario de Valme. Sevilla
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00546442     History of Changes
Other Study ID Numbers: 2005-02446-19
Study First Received: October 17, 2007
Last Updated: October 17, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Valme University Hospital:
insulin resistance
chronic hepatitis C
genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Peginterferon alfa-2a
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014