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

Phase 4

Conditions: Health Condition 1: B182- Chronic viral hepatitis C

Registration Number: CTRI/2015/02/005494

Lead Sponsor: Virchow Biotech Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percentage of patients with sustained virological response (defined as undetectable serum HCV RNA 24 weeks after cessation of therapy).Timepoint: at 72 weeks

Secondary Outcome Measures

Name	Time	Method
2.Percentage of patients with normalisation of ALT at 12, 24 weeks and 48 weeks and 24 weeks after cessation of therapy.Timepoint: at 12, 24 weeks and 48 weeks;Percentage of patients with undetectable serum HCV RNA at 12, 24 weeks and at 48 weeksTimepoint: at 12, 24 weeks and at 48 weeks