Phase 4 N=100 Treatment

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

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT06922643 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Sustained Virological Response (SVR) — 17; 10; 56; 83 Participants — p=0.008

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Peginterferon Alfa-2A (Drug); Ribavirin Oral Product (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained Virological Response (SVR)	17; 10; 56; 83	0.008 sig
SECONDARY Rapid Virological Response (RVR)	19; 12; 57	—
SECONDARY Complete Early Virological Response (cEVR)	24; 13; 63	—
SECONDARY End of Treatment Response (ETR)	22; 13; 62	—
SECONDARY Safety (Adverse Events)	100	—

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

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06922643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.