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

Phase 4

Completed

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

• Registration Number: CTRI/2011/091/000028
• Lead Sponsor: Virchow Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-02-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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 � 109/L; neutrophil count greater than or equal to1.5 � 109/L; thyroid stimulating hormone (TSH) within normal limits (0.35 - 5.50 µIU/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, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with undetectable serum HCV RNA at 12, 24 weeks and at 48 weeksTimepoint: 12, 24 weeks and at 48 weeks <br/ ><br>48 weeks Only for patients with genotypes 1 & 4