Efficacy and safety of PEG-Inferon (peginterferon alpha-2b) for the treatment of chronic hepatitis C

Virchow Biotech0 sites100 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 1, 2013

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Virchow Biotech

•1\.Adult male or female between 18\-65 years (both years inclusive).
•2\.Patients 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 greater than or equal to 9 g/dL (females),greater than or equal to 10 g/dL (males); platelet count greater than or equal to75 Ã? 109/L; neutrophil count greater than or equal to1\.5 Ã? 109/L; thyroid stimulating hormone (TSH) within normal limits (0\.35 \- 5\.50 ÂµIU/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, Wilson?s disease, primary biliary cirrhosis, alcoholic liver disease or autoimmune liver disease, hemochromatosis.
•2\.A chronic alcoholic or drug abuse problem or severe psychiatric condition.
•3\.Pregnant or intent to be pregnant during the study period or nursing mothers.
•4\.Patients 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\.Patients with human immunodeficiency virus (HIV) infection.