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NCT Number: NCT06922643

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

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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peginterferon alfa-2a

Drug

180 mcg, subcutaneous injection, once weekly

Other names: Pegnano (Peginterferon alfa-2a)

Ribavirin Oral Product

Drug

15 mg/kg daily, oral (1200 mg/day for body weight >80 kg)

Other names: Barivir

Primary outcomes

  1. Sustained Virological Response (SVR)

    Time frame: 24 weeks post-treatment

    Percentage of patients with undetectable HCV RNA 24 weeks after treatment completion, measured by real-time reverse transcriptase PCR. In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy.

    In this study, SVR and SVR24 are interchangeable.

Secondary outcomes

  1. Rapid Virological Response (RVR)

    Time frame: Week 4

    Percentage of patients with undetectable HCV RNA at week 4, measured by real-time reverse transcriptase PCR.

    In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy.

  2. Complete Early Virological Response (cEVR)

    Time frame: Week 12

    Percentage of patients with undetectable HCV RNA at week 12 (in non-RVR patients), measured by real-time reverse transcriptas PCR.

    In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy.

  3. End of Treatment Response (ETR)

    Time frame: End of treatment: 24 weeks for genotypes 2 and 3; 48 weeks for genotypes 1, 4, 5, and 6. For genotypes 1 and 4, extend to 72 weeks if only LVR is achieved. For genotypes 2 and 3, extend to 48 weeks if non-RVR but EVR is present.

    Percentage of patients with undetectable HCV RNA at the end of treatment, measured by real-time PCR.

  4. Safety (Adverse Events)

    Time frame: Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)

    Incidence and severity of clinical and paraclinical adverse events (e.g., anemia, neutropenia, depression), assessed every 4 weeks

Sponsors and collaborators

Lead sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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