Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: IDX184
* Biological: Peginterferon alfa-2a (Peg-IFN)
* Drug: Ribavirin (RBV)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDX184 50 mg + Peg-IFN/RBV<br>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. | Drug: IDX184<br>* IDX184 50 mg tablet administered orally<br>Biological: Peginterferon alfa-2a (Peg-IFN)<br>* Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly<br>* Other names: Pegasys;Drug: Ribavirin (RBV)<br>* 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.<br>Drug: Placebo<br>* Matching placebo to IDX184 50 mg tablet administered orally<br>|
| Experimental: IDX184 100 mg + Peg-IFN/RBV<br>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. | Drug: IDX184<br>* IDX184 50 mg tablet administered orally<br>Biological: Peginterferon alfa-2a (Peg-IFN)<br>* Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly<br>* Other names: Pegasys;Drug: Ribavirin (RBV)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve undetectable HCV RNA viral levels 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, treatment-naive