PER-040-01已完成未知
TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS B (HCB) USING PEG-INTERFERON ALPHA 2B
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
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