FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/091/000028
Enrollment
100
Registered
2011-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B182- Chronic viral hepatitis C

Interventions

Intervention1: Peg-Inferon: 1.5 µg/kg/wk of PEG-Inferon + Ribavirin 800 mg/day for 24 weeks for genotypes 2 and 3. PEG-Inferon (1.5 µg/kg/wk) + Ribavirin(800 mg/day for &#8804
65 kg
1000 mg/day for 65- 85 kg
1200 mg/day for 85-105 kg
1400 mg/day for 105 kg) will be administered for 48 weeks for genotypes 1 and 4. Control Intervention1: Nil: Nil

Sponsors

Virchow Biotech
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
Percentage of patients with sustained virological response (defined as undetectable serum HCV RNA ).Timepoint: 24 weeks after cessation of therapy—

Secondary

MeasureTime frame
Percentage of patients with undetectable serum HCV RNA at 12, 24 weeks and at 48 weeksTimepoint: 12, 24 weeks and at 48 weeks 48 weeks Only for patients with genotypes 1 & 4—

Countries

India

Contacts

Public ContactDr TC Raghuram
tcraghuram@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026