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

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon Alfa-2A; Drug: Ribavirin Oral Product

• Registration Number: NCT06922643
• Lead Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company

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

Study Timeline

• Study Start: 2011-03-01
• Primary Completion: 2013-01-21
• Study Completion: 2013-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegnano (Peginterferon alfa-2a)	Peginterferon Alfa-2A	-
Pegnano (Peginterferon alfa-2a)	Ribavirin Oral Product	-

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response at 24 Weeks (SVR24)	24 weeks post-treatment	Percentage of patients with undetectable HCV RNA 24 weeks after treatment completion, measured by real-time reverse transcriptase PCR.

Secondary Outcome Measures

Name	Time	Method
Rapid Virological Response (RVR)	Week 4	Percentage of patients with undetectable HCV RNA at week 4, measured by real-time PCR.
Complete Early Virological Response (cEVR)	Week 12	Percentage of patients with undetectable HCV RNA at week 12 (in non-RVR patients), measured by real-time PCR
End of Treatment Response (EOT)	End of treatment (24, 48, or 72 weeks depending on genotype)	Percentage of patients with undetectable HCV RNA at the end of treatment, measured by real-time PCR.
Safety (Adverse Events)	Throughout treatment (up to 72 weeks)	Incidence and severity of clinical and paraclinical adverse events (e.g., anemia, neutropenia, depression), assessed every 4 weeks