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

NCT06922643 | Completed Phase 4 Results

• 1 other identifier: NNG00
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks post-treatment

Secondary Outcomes (4)

• Rapid Virological Response (RVR)

  Week 4

• Complete Early Virological Response (cEVR)

  Week 12

• 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.

• Safety (Adverse Events)

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

Study Arms (1)

Pegnano (Peginterferon alfa-2a)

EXPERIMENTAL

Drug: Peginterferon Alfa-2A; Drug: Ribavirin Oral Product

Interventions

Peginterferon Alfa-2A DRUG

180 mcg, subcutaneous injection, once weekly

Also known as: Pegnano (Peginterferon alfa-2a)

Pegnano (Peginterferon alfa-2a)

Ribavirin Oral Product DRUG

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

Also known as: Barivir

Pegnano (Peginterferon alfa-2a)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Thuy Phuong Nguyen
• Organization: Nanogen Biopharmaceutical JSC

phuongthuy@nanogenpharma.com

+84 903 754 559

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: March 1, 2011
• Primary Completion: January 21, 2013
• Study Completion: March 1, 2013
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-05