Trial Outcomes & Findings for Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital (NCT NCT06922643)

Last Updated: 2025-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

24 weeks post-treatment

Results posted on

2025-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	100
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
Age, Continuous	47 years STANDARD_DEVIATION 11 • n=100 Participants
Sex: Female, Male Female	34 Participants n=100 Participants
Sex: Female, Male Male	66 Participants n=100 Participants
Weight (kg)	62.4 kg STANDARD_DEVIATION 10 • n=100 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
Sustained Virological Response (SVR) G1	17 Participants
Sustained Virological Response (SVR) G2	10 Participants
Sustained Virological Response (SVR) G6	56 Participants
Sustained Virological Response (SVR) Total	83 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Total number of participants by viral genotype: 100 * Genotype 1: 24 participants * Genotype 2: 13 participants * Genotype 6: 63 participants

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.

Outcome measures

Outcome measures
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
Rapid Virological Response (RVR) G1	19 Participants
Rapid Virological Response (RVR) G2	12 Participants
Rapid Virological Response (RVR) G6	57 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Total number of participants by viral genotype: 100 * Genotype 1: 24 participants * Genotype 2: 13 participants * Genotype 6: 63 participants

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.

Outcome measures

Outcome measures
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
Complete Early Virological Response (cEVR) G1	24 Participants
Complete Early Virological Response (cEVR) G2	13 Participants
Complete Early Virological Response (cEVR) G6	63 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
End of Treatment Response (ETR) G1	22 Participants
End of Treatment Response (ETR) G2	13 Participants
End of Treatment Response (ETR) G6	62 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pegnano (Peginterferon Alfa-2a) n=100 Participants 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)
Safety (Adverse Events)	100 Participants

Adverse Events

Pegnano (Peginterferon Alfa-2a)

Serious events: 0 serious events

Other events: 100 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pegnano (Peginterferon Alfa-2a) n=100 participants at risk 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)
Skin and subcutaneous tissue disorders Alopecia	78.0% 78/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Metabolism and nutrition disorders Anorexia	58.0% 58/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Gastrointestinal disorders Sluggish	41.0% 41/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Psychiatric disorders Insomnia	35.0% 35/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
General disorders Chill	33.0% 33/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Musculoskeletal and connective tissue disorders Myalgia	29.0% 29/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
General disorders Mild pyrexia (without use of Paracetamol)	22.0% 22/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
General disorders Moderate Pyrexia (with use of Paracetamol)	19.0% 19/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
General disorders Fatigue	22.0% 22/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Psychiatric disorders Mild depression	13.0% 13/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Psychiatric disorders Moderate depression	9.0% 9/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Skin and subcutaneous tissue disorders Pruritus	20.0% 20/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
General disorders Erythema at injection site	11.0% 11/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Nervous system disorders Headache	10.0% 10/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Nervous system disorders Dizziness	6.0% 6/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Respiratory, thoracic and mediastinal disorders Cough	7.0% 7/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Endocrine disorders Hyperthyroidism with paraclinical evidences	4.0% 4/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)
Endocrine disorders Hypothyroidism with paraclinical evidences	3.0% 3/100 • Throughout treatment (up to 72 weeks) and 24 weeks post-treatment (up to week 96)

Additional Information

Dr. Thuy Phuong Nguyen

Nanogen Biopharmaceutical JSC

Phone: +84 903 754 559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place