PER-039-01
Completed
未知
TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C (HCC) USING PEG-INTERFERON ALPHA 2B AND RIBAVIRINE
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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).
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
Outcomes
Primary Outcomes
Not specified
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