None listed
Conditions
Interventions
PEG INTERFERON ALFA-2B Type of group
Patients> 65 K weight: 100 mcg SC once a week for 32 weeks.
Patients
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or adult woman, patients with chronic hepatitis B between 18 and 70 years of age • Patients not previously treated for chronic hepatitis B or patients who previously failed treatment with interferon alfa. • The patient must have documentation of positive serum HBsAg for a minimum of 6 months prior to entering the study. • The patient must show evidence of HBV replication documented by: o serum-positive HBV DNA within 3 months prior to entry o positive serum HBeAg within 3 months prior to entry. o elevated alanine aminotransferase (TGP) above the upper limit of normal, within 6 months prior to entry o Compensated liver disease • 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%. The 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 are eligible if they meet all other inclusion / exclusion criteria.). • Antinuclear Antibodies (ANA) <1: 160 • Value of alpha-fetoproteins within the normal limits obtained within a period of one year prior to entry into the study. Results above the upper limit of normal but <50 mg / ml • Negative Hepatitis C serum antigen • HIV negative (Positive ELISA results will be confirmed by Western Blot) • If there is a history of diabetes or hypertension, an eye examination is required. • Written informed consent • Reconfirmation that sexually active women with the possibility of getting pregnant are using some appropriate contraceptive method (intra uterine device, diaphragm ± spermicide or condom ± spermicide, oral contraceptives, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-Provera), sterilization surgical, or monogamous relationship with a male partner who has had a vasectomy) during the period of treatment. Women patients should not be breastfeeding. • 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.
Exclusion criteria
Exclusion criteria: • Patients over 70 years of age • Women who are pregnant or breastfeeding • Suspected hypersensitivity to interferon or PEG-interferon. • Participation in any other clinical trial within 30 days prior to entering this study. • Treatment with any investigational drug within 30 days prior to entry into 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 (where applicable) other than chronic hepatitis B • Known positivity of HTV • Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy • 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), LV 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:Loss of markers in the serum of hepatitis B virus replication (both HBeAg and HBV DNA) Measure:Markers in the serum of hepatitis B virus replication Timepoints:32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum tests of HBsAg and serum transaminases Measure:Effect of therapy on HBsAg and serum transaminases Timepoints:32 weeks ; Outcome name:Complete Response: TGP figures within normal limits and / or negative HBV-DNA. Measure:Response to combined treatment Timepoints:It will be determined at the end of the 32 weeks of treatment and 6 months after finishing the treatment. ; Outcome name:Any serious adverse event, whether or not expected or related to the drug, should be reported by the attending physician. Measure:Adverse events Timepoints:When the adverse event appears | — |
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed