Efficacy and safety of PEG-Inferon (peginterferon alpha-2b) for the treatment of chronic hepatitis C - An open-label multicentre study in India.

Virchow Biotech Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Adult male or female between 18-65 years (both years inclusive).
•2.Patient with chronic hepatitis C infection.
•3. Presence of serum alanine aminotransferase (ALT)
•levels 1.5 times greater than normal (N <40 IU/litre).
•4.Compensated liver disease at the time of baseline
•visit as defined by Child-Pugh class A.
•5.Hemoglobin >=9 g/dL (females), >=10 g/dL (males); platelet count >=75 Ã? 109/L; neutrophil count >=1.5 Ã? 109/L; thyroid stimulating hormone (TSH) within normal limits (0.35 â?? 5.50 mIU/mL).
•6.Willing to give written informed consent and adhere to study visit schedule

•1.Any evidence of other liver diseases HAV, HBV, HDV, alpha 2 anti-trypsin deficiency, Wilsonâ??s disease, primary biliary cirrhosis, alcoholic liver disease or autoimmune liver disease, hemochromatosis.
•2.A chronic alcoholic or patient with drug abuse problem or severe psychiatric condition.
•3.Pregnant or intent to be pregnant during the study period or nursing mothers.
•4.Patient with immune suppression associated with organ transplantation especially liver transplantation.
•5.History of hypersensitivity to interferon or its diluents. Significant psychiatric disease especially depression.
•6.Severe cardiovascular disease.
•7.Patient with human immunodeficiency virus (HIV) infection.

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