None listed
Conditions
Interventions
Group 1 Type of group
Interferon alfa 2A 3 MIO (millions of international units), subcutaneously, 3 times a week (Monday, Wednesday and Friday), for 12 months.
Group name:Group 2 Type of group
Interferon alfa 2A 3 MIO (millions of international units), subcutaneously, 3 times a week (Monday, Wednesday and Friday), for 12 months + Ribavirin, will be used at a dose of 15 mg / kg / day in two doses, for 12 months
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Ambulatory patients of both sexes, aged between 18 and 60 years old, diagnosed with chronic Hepatitis C, by means of: Anti HCV, RNA-HCV (Use of ELISA 3rd generation, POR. • You must not have received previous treatment for your chronic liver problem. • Liver biopsy (maximum 12 months before). • Persistent elevation of transaminases 1.5 times the normal values (dosages 2 to 4 weeks before treatment), proteins: albumin> 3.5 gr / dL, normal bilirubins. • Hemoglobin> 12 g / dL in men and> 11 g / dL in women • Prothrombin time 80% concentration. • Normal blood glucose, normal TSH, creatinine <1.4 mg / ml, ultrasonography without probable images of neoplasms or tumors.
Exclusion criteria
Exclusion criteria: • Coinfection with Hepatitis B (HbsAg + / Anti-HBcAg +), HIV (ELISA, PCR, W. Blot +). • Coexisting liver diseases: Hemochromatosis, alpha 1 antitrypsin deficiency, alcoholic liver disease, liver disease due to obesity or drugs. • Alpha fetus protein (AFP)> 50 ng / ml. • Advanced and / or decompensated liver disease: ascites, portal hypertension, hemorrhage due to esophageal varices, etc. • Hemophilia. • Anemia: hemoglobin <12 g / dL in men and <11 g / dL in women. • Convulsive disorders. • Psychiatric disorders: schizophrenia, depression, manic depression, etc. • Cardiovascular disorders: heart failure, arrhythmia; cardiovascular risk factors: hyperlipidemias, obesity. • Diabetes mellitus not controlled. • Chronic lung disease. • Immune or autoimmune diseases: Ulcerative colitis, Crohn´s disease, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, psoriasis, cryoglobulinemia. • Chronic renal insufficiency. •Gestation • Women who can not or want to use safe contraceptive methods (IUD, oral contraceptives, injectable contraceptives). • Uncontrolled gout.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• COMPLETE ANSWER: Disappearance of the virus at the serum level, using PCR sensitive to 100 copies / ml. • FAILURE TO TREATMENT: Persistence of the virus at the end of 48 weeks of treatment. Measure:Response to treatment Timepoints:After the administration of treatment | — |
Outcome results
None listed