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

Nanogen Pharmaceutical Biotechnology

Status and phase

Completed

Phase 4

Conditions

Chronic Hepatitis C

Treatments

Drug: Ribavirin Oral Product

Drug: Peginterferon Alfa-2A

Study type

Interventional

Funder types

Industry

Identifiers

NCT06922643

NNG00

Details and patient eligibility

About

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

Full 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

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.