Clinical trial NCT06922643: Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital
Official title: Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Lead sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Sustained Virological Response at 24 Weeks (SVR24)
timeFrame: 24 weeks post-treatment
Secondary outcomes:
measure: Rapid Virological Response (RVR)
timeFrame: Week 4
measure: Complete Early Virological Response (cEVR)
timeFrame: Week 12
measure: End of Treatment Response (EOT)
timeFrame: End of treatment (24, 48, or 72 weeks depending on genotype)
measure: Safety (Adverse Events)
timeFrame: Throughout treatment (up to 72 weeks)
Other outcomes:
Locations:
Study officials:
References: