Status:
COMPLETED
Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 Hospita...
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 Ge...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06922643
Start Date
March 1 2011
End Date
March 1 2013
Last Update
June 29 2025
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