Chronic Hepatitis C
Conditions
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
Interventions
DRUGPeginterferon Alfa-2A
180 mcg, subcutaneous injection, once weekly
15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg)
Sponsors
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response (SVR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Rapid Virological Response (RVR) | 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. |
| Complete Early Virological Response (cEVR) | 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. |
| End of Treatment Response (ETR) | 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. |
| Safety (Adverse Events) | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegnano (Peginterferon Alfa-2a) Peginterferon Alfa-2A: 180 mcg, subcutaneous injection, once weekly
Ribavirin Oral Product: 15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg) | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Pegnano (Peginterferon Alfa-2a) | — |
|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 66 Participants | — |
| Weight (kg) | 62.4 kg STANDARD_DEVIATION 10 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 100 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Sustained Virological Response (SVR)
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.
Time frame: 24 weeks post-treatment
Population: Total number of participants by viral genotype: 100~* Genotype 1: 24 participants~* Genotype 2: 13 participants~* Genotype 6: 63 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pegnano (Peginterferon Alfa-2a) | Sustained Virological Response (SVR) | G1 | 17 Participants |
| Pegnano (Peginterferon Alfa-2a) | Sustained Virological Response (SVR) | G2 | 10 Participants |
| Pegnano (Peginterferon Alfa-2a) | Sustained Virological Response (SVR) | G6 | 56 Participants |
| Pegnano (Peginterferon Alfa-2a) | Sustained Virological Response (SVR) | Total | 83 Participants |
p-value: 0.00895% CI: [1.63, 27.8]Regression, Logistic
Secondary
Complete Early Virological Response (cEVR)
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.
Time frame: Week 12
Population: Total number of participants by viral genotype: 100~* Genotype 1: 24 participants~* Genotype 2: 13 participants~* Genotype 6: 63 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pegnano (Peginterferon Alfa-2a) | Complete Early Virological Response (cEVR) | G1 | 24 Participants |
| Pegnano (Peginterferon Alfa-2a) | Complete Early Virological Response (cEVR) | G2 | 13 Participants |
| Pegnano (Peginterferon Alfa-2a) | Complete Early Virological Response (cEVR) | G6 | 63 Participants |
Secondary
End of Treatment Response (ETR)
Percentage of patients with undetectable HCV RNA at the end of treatment, measured by real-time PCR.
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.
Population: Total number of participants by viral genotype: 100~* Genotype 1: 24 participants~* Genotype 2: 13 participants~* Genotype 6: 63 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pegnano (Peginterferon Alfa-2a) | End of Treatment Response (ETR) | G1 | 22 Participants |
| Pegnano (Peginterferon Alfa-2a) | End of Treatment Response (ETR) | G2 | 13 Participants |
| Pegnano (Peginterferon Alfa-2a) | End of Treatment Response (ETR) | G6 | 62 Participants |
Secondary
Rapid Virological Response (RVR)
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.
Time frame: Week 4
Population: Total number of participants by viral genotype: 100~* Genotype 1: 24 participants~* Genotype 2: 13 participants~* Genotype 6: 63 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pegnano (Peginterferon Alfa-2a) | Rapid Virological Response (RVR) | G1 | 19 Participants |
| Pegnano (Peginterferon Alfa-2a) | Rapid Virological Response (RVR) | G2 | 12 Participants |
| Pegnano (Peginterferon Alfa-2a) | Rapid Virological Response (RVR) | G6 | 57 Participants |
Secondary
Safety (Adverse Events)
Incidence and severity of clinical and paraclinical adverse events (e.g., anemia, neutropenia, depression), assessed every 4 weeks
Time frame: Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pegnano (Peginterferon Alfa-2a) | Safety (Adverse Events) | 100 Participants |