Phase 4
Completed N=100
Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital
Source: ClinicalTrials.gov NCT06922643 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Sustained Virological Response (SVR) — 17; 10; 56; 83 Participants — p=0.008
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
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 | — |
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.
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. Informational only — not medical advice.