TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C (HCC) USING PEG-INTERFERON ALPHA 2B AND RIBAVIRINE

Not Applicable

• Conditions: -B182 Chronic viral hepatitis C; Chronic viral hepatitis C; B182

• Registration Number: PER-039-01
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified