Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT ID: NCT06922643

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-01
• Study Completion Date: 2013-03-01

Brief Summary

This study presents a clinical study on the efficacy and safety of Pegnano combined with Barivir (Ribavirin) in treating treatment-naïve patients with Chronic Hepatitis C at Kien Giang General Hospital. The study aims to provide affordable treatment options while evaluating the virological response and side effects associated with the therapy

Detailed Description

This study evaluates the efficacy and safety of Pegnano (Peginterferon alfa-2a) combined with Barivir (Ribavirin) in treatment-naïve patients with chronic hepatitis C (HCV). Conducted at Kien Giang General Hospital from March 2011 to March 2013, this uncontrolled clinical trial enrolled 100 outpatients aged 18-65 with HCV RNA >80 IU/mL and compensated liver disease. Patients received Pegnano (180 mcg, subcutaneous, weekly) and Barivir (15 mg/kg daily, oral) for 24 weeks (genotypes 2, 3) or 48 weeks (genotypes 1, 4, 5, 6), with possible extension to 72 weeks for genotype 1 with late virological response. The primary goal is to assess virological responses (rapid, early, end-of-treatment, and sustained at 24 weeks) by genotype and IL28B rs12979860 polymorphism, alongside safety through adverse event monitoring. Efficacy is measured via HCV RNA levels using real-time PCR, while safety is evaluated through clinical and paraclinical assessments every 4 weeks. The study aims to provide evidence for affordable HCV treatment options in Vietnam using locally produced drugs

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegnano (Peginterferon alfa-2a)

Group Type: EXPERIMENTAL

Peginterferon Alfa-2A

Intervention Type: DRUG

180 mcg, subcutaneous injection, once weekly

Ribavirin Oral Product

Intervention Type: DRUG

15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg)

Interventions

Peginterferon Alfa-2A

180 mcg, subcutaneous injection, once weekly

Intervention Type: DRUG

Ribavirin Oral Product

15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg)

Intervention Type: DRUG

Other Intervention Names

Pegnano (Peginterferon alfa-2a); Barivir

Eligibility Criteria

Inclusion Criteria

• Patients with chronic hepatitis C.
• Age 18-65 years.
• No previous treatment with interferon or peginterferon.
• HCV RNA serum baseline >80 IU/mL.
• Compensated liver disease (total bilirubin <25.6 µmol/L, INR <1.5, serum albumin >3.4 g/dL, no ascites or hepatic encephalopathy).
• Normal hematological and biochemical parameters (hemoglobin >12 g/dL for males, >11 g/dL for females; neutrophils >1500 cells/µL; platelets >75,000 cells/µL; serum creatinine <1.5 mg/dL or <132 µmol/L).

Exclusion Criteria

• Depression.
• Autoimmune hepatitis or other autoimmune diseases.
• Unstable hyperthyroidism or hypothyroidism.
• Severe medical conditions (e.g., hypertension, congestive heart failure, angina, uncontrolled diabetes, COPD).
• Decompensated cirrhosis.
• Co-infection with HIV or hepatitis B.
• Pregnant women or those unwilling to use effective contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanogen Pharmaceutical Biotechnology Joint Stock Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NNG00

Identifier Type: -

Identifier Source: org_study_id