PER-040-01
Completed
未知
TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS B (HCB) USING PEG-INTERFERON ALPHA 2B
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
- •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.).
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
Outcomes
Primary Outcomes
Not specified
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