Chronic Hepatitis CPhase 4NCT06922643
Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital
A Phase 4 study testing Peginterferon Alfa-2A and Ribavirin Oral Product in people with Chronic Hepatitis C, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon Alfa-2A and Ribavirin Oral Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 1 Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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
Read the 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
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon Alfa-2A, Ribavirin Oral Product
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Alfa-2ADrug
Also called Pegnano (Peginterferon alfa-2a)
180 mcg, subcutaneous injection, once weekly
Ribavirin Oral ProductDrug
Also called Barivir
15 mg/kg daily, oral (1200 mg/day for body weight >80 kg)
| Study group | Role | What they receive |
|---|---|---|
| Pegnano (Peginterferon alfa-2a) | Experimental | Not described Receives: Drug: Peginterferon Alfa-2A; Drug: Ribavirin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-treatment
Secondary outcomes (4)
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.
Measured: Week 4
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.
Measured: Week 12
End of Treatment Response (ETR)
Percentage of patients with undetectable HCV RNA at the end of treatment, measured by real-time PCR.
Measured: 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.
Safety (Adverse Events)
Incidence and severity of clinical and paraclinical adverse events (e.g., anemia, neutropenia, depression), assessed every 4 weeks
Measured: Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Mar 2011
- Primary completion21 Jan 2013
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922643
- Sponsor's protocol ID
- NNG00
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06922643
- Acronym / sponsor ID
- NNG00
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 21 Jan 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegnano (Peginterferon alfa-2a) | Experimental | Drug: Peginterferon Alfa-2A, Drug: Ribavirin Oral Product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon Alfa-2AAlso: Pegnano (Peginterferon alfa-2a)180 mcg, subcutaneous injection, once weekly | Drug | Pegnano (Peginterferon alfa-2a) |
| Ribavirin Oral ProductAlso: Barivir15 mg/kg daily, oral (1200 mg/day for body weight >80 kg) | Drug | Pegnano (Peginterferon alfa-2a) |
Primary outcome
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.
4 secondary outcomes
Rapid Virological Response (RVR)
Time frame: Week 4
Complete Early Virological Response (cEVR)
Time frame: Week 12
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.
Safety (Adverse Events)
Time frame: Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon Alfa-2A and Ribavirin Oral Product in people with Chronic Hepatitis C, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response (SVR) (time frame: 24 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.