This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,469
Percentage of Participants With Sustained Virological Response (SVR)
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
Time frame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Percentage of Participants With Virological Response at The End of Study Treatment
Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.
Time frame: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Percentage of Participants Virological Response 12 Weeks Post-Treatment
Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.
Time frame: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
180 micrograms sc weekly for 24 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Anchorage, Alaska, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palo Alto, California, United States
...and 122 more locations
Time frame: Up to Week 40 and Week 48
Percentage of Participants With Marked Laboratory Abnormalities
Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.
Time frame: Up to Week 40 and Week 48
Participants With Marked Abnormal Vital Signs
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Time frame: Up to Week 40 and Week 48
Number of Participants With Highest Triglyceride Level
Participants with triglyceride level above normal (i.e. \< 200 mg/dL) were analysed.
Time frame: Up to Week 40 and Week 48