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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-08C-005 | Other Identifier | Idenix Protocol Number | |
| 2011-001878-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDX184 50 mg + Peg-IFN/RBV | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX184 | Drug | IDX184 50 mg tablet administered orally |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C557801 | IDX184 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Peginterferon alfa-2a (Peg-IFN) | Biological | Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly |
|
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| Ribavirin (RBV) | Drug | 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. |
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| Placebo | Drug | Matching placebo to IDX184 50 mg tablet administered orally |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |