Treatment Insulin Resistence in HCV G-1 Patient

NCT00546442 | Completed Phase 4 DMC

• 1 other identifier: 2005-02446-19
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 19

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.

Conditions

Chronic Hepatitis C

Keywords

insulin resistance; chronic hepatitis C; genotype 1

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with HCV-RNA

  Week 72

Secondary Outcomes (1)

• Percentage of patients who has erradicated the insulin resistance

  week 72

Study Arms (2)

2

PLACEBO COMPARATOR

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

Other: Placebo of metformine

1

EXPERIMENTAL

Metformine 850-2550 mg/daily for 48 weeks

Drug: Metformine

Interventions

Metformine DRUG

850-2550 mg/daily for 48 weeks

1

Placebo of metformine OTHER

850-2550 mg/daily for 48 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valme University Hospital: lead

Study Sites (19)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital Clínico Universitario San Cecilio

Granada, Granada, 18003, Spain

Location

Hospital Virgen de las Nieves

Granada, Granada, 18004, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital de Leon

León, Leon, 24071, Spain

Location

Fundación Hospital de Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Carlos III

Madrid, Madrid, 28029, Spain

Location

Hospital Puerta de Hierro

Madrid, Madrid, 28035, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Hospital Universitario de Valme

Seville, Sevilla, 41014, Spain

Location

Hospital General Universitario

Valencia, Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Manuel Romero-Gomez, Dr

  Hospital Universitario de Valme. Sevilla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 19, 2007
• Study Start: May 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 19, 2007

Record last verified: 2007-10

Locations

ES (19)