Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
Phase 2
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01371604
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- Males and females with documented genotype 1, chronic hepatitis C infection.
- Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
- Has not received prior antiviral treatment for HCV.
- Written informed consent by participant.
Exclusion Criteria
- Pregnant or breastfeeding.
- Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDX184 100 mg + Peg-IFN/RBV Peginterferon alfa-2a (Peg-IFN) IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 50 mg + Peg-IFN/RBV Placebo IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 50 mg + Peg-IFN/RBV Peginterferon alfa-2a (Peg-IFN) IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 50 mg + Peg-IFN/RBV Ribavirin (RBV) IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 100 mg + Peg-IFN/RBV IDX184 IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 100 mg + Peg-IFN/RBV Ribavirin (RBV) IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. IDX184 50 mg + Peg-IFN/RBV IDX184 IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.
- Primary Outcome Measures
Name Time Method Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 Week 12 Percentage of participants who experience a serious adverse event Up to Week 16 and end of treatment (Weeks 24 or 48) Percentage of participants who experience an adverse event 16 weeks Percentage of participants who experience a grade 1-4 laboratory abnormality 16 weeks
- Secondary Outcome Measures
Name Time Method Percentage of participants who achieve sustained virologic response (SVR) 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 Week 4 Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment Weeks 24 or 48 Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4 Week 4 Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment Weeks 24 or 48 Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose) Weeks 48 or 72