The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
IDX184 50 mg tablet administered orally
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.
Percentage of participants who experience a serious adverse event
Time frame: Up to Week 16 and end of treatment (Weeks 24 or 48)
Percentage of participants who experience an adverse event
Time frame: 16 weeks
Percentage of participants who experience a grade 1-4 laboratory abnormality
Time frame: 16 weeks
Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
Time frame: Week 12
Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
Time frame: Week 4
Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
Time frame: Weeks 24 or 48
Percentage of participants who achieve sustained virologic response (SVR)
Time frame: 24 weeks after the last dose (Weeks 48 or 72)
Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
Time frame: Week 4
Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
Time frame: Weeks 24 or 48
Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)
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Matching placebo to IDX184 50 mg tablet administered orally
Time frame: Weeks 48 or 72