None listed
Conditions
Interventions
Group 1 Type of group
PATIENTS> 65 KG WEIGHT INDUCTION PHASE: 100 uG SC ONCE A WEEK FOR 4 WEEKS FOLLOWED BY
COMBINED PHASE: 50 pG SC ONCE A WEEK UNTIL COMPLETE 52 WEEKS (12 MONTHS)
PATIENTS 75 KG OF WEIGHT: 1200 MG DAILY (2 DOSES DIVIDED: 3 CAPSULES IN THE MORNING AND 3 IN THE NIGHT) UNTIL COMPLETE 52 W
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients with HCC woman or adult male, 18 to 70 years of age. • Liver disease compensated with the following minimum hematological and biochemical criteria: - Hemoglobin> 13 g / day for men,> 12 g / day for women - White blood cell count> 3,000 / mm ^ - Granulocyte count> 1,500 / mm ^ - Platelets> 100,000 / mm ^ - Direct and indirect bilirubin within normal limits (unless factors unrelated to hepatitis such as Gilbert´s disease explain an elevation of indirect bilirubin.In such cases indirect bilirubin should be <3.0 mg / dl or < 51.3 umol / 1) - Albumin within normal limits - Serum creatinine within normal limits • Fasting glucose should be 70-115 mg / dl. Results between 115-140 mg / dl require repeating the fasting glucose test to be <140 mg / dl and Hb A1c (glycosylated hemoglobin) <8.5%. Hemoglobin Ale should be <8.5% for diabetic patients (even when in control with diet or medication). • Thyroid Stimulating Hormone (TSH), within normal limits (Patients requiring medication to maintain TSH levels in the normal range will be eligible if they meet all other inclusion criteria). • Antinuclear Antibodies (ANA) <1: 160 • Alphafetoprotein value within normal limits, obtained within the year prior to entry into the study. • HTV negative (positive ELISA results will be confirmed by Western n Blot) • The patient must be seronegative for the surface antigen (HBsAg) of Hepatitis B. • Elevated TGP before entering the study • Sero positive for hepatitis C virus by bDNA or PCR / RNAVHC assay. • Liver biopsy (optional) within 12 months prior to admission to this study with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis. • If there is a history of diabetes or hypertension, an eye examination is indicated prior to therapy • Reconfirmation that sexually active women with a chance of getting pregnant are practicing an adequate method of contraception (intra uterine device, diaphragm + spermicide or condom + spermicide, oral contraceptives, progesterone implant rods (Norplant), medroxyprogesterone acetate (Depo-Provera ), surgical sterilization, or monogamous relationship with a male partner who has had a vasectomy) during the period of treatment and for 6 months after the discontinuation of therapy. • Reconfirmation that sexually active men are using acceptable methods of contraception (vasectomy, condom + spermicide, monogamous relationship with a woman partner who practices an acceptable method of contraception) during the period of treatment and for 6 months after discontinuation of therapy . Female patients should not breastfeed during the period of treatment.
Exclusion criteria
Exclusion criteria: • Patients older than 70 years of age • Pregnant or lactating women • Suspected hypersensitivity to interferon, PEG-interferon or ribavirin. • Participation in any other clinical trial within 30 days prior to entering this study. • Treatment with any investigational drug within 30 days prior to entering this study. • Patients with organ transplants other than cornea and hair transplant • Any cause of liver disease based on the patient´s history and biopsy (when required) other than chronic hepatitis C • Known positivity of HIV • Patients with hemophilia or any hemoglobinopathy including but not limited to thalassemia major and minor. • Any known pre-existing medical condition that could interfere with the patient´s participation and its completion in the study • Any medical condition that requires, or will likely require, during the course of the study, a chronic, systematic administration of steroids. • Clinical Drop • Substance abuse, such as alcohol (> 80 g / day), IV drugs. or drugs that are inhaled. If the patient has a history of substance abuse, to be considered for inclusion in the study, the patient must have abstained from using the substance of abuse for at least 2 years. Patients who received methadone within the last 2 years are also excluded. • Patients with significant abnormalities in the retina. • Patients who do not wish to be advised or who do not wish to abstain from alcohol consumption. • Any other condition that in the opinion of the investigator would make the patient unfit for inclusion, or that could interfere with the patient´s participation to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete Response: TGP figures within normal limits and / or negative HCV-RNA Measure:Response to combined treatment Timepoints:At the end of 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Any serious adverse event, whether or not expected or related to the drug, should be reported to the attending physician. Measure:Appearence of Adverse events Timepoints:When the event appears | — |
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed