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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-08C-004 | Other Identifier | Idenix Protocol Number |
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This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDX184 50 mg QD + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28. |
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| IDX184 100 mg QD + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28. |
|
| IDX184 100 mg BID + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28. |
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| IDX184 150 mg QD + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDX184 | Drug | IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15 | Baseline and Day 15 | |
| Percentage of participants experiencing adverse events (AEs) | Up to 28 days | |
| Percentage of participants experiencing serious adverse events (SAEs) | Up to 28 days | |
| Percentage of participants experiencing dose-limiting toxicities (DLTs) | Up to 28 days | |
| Percentage of participants experiencing Grade 1-4 laboratory abnormalities | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV RNA level from Baseline to Day 28 | Baseline and Day 28 | |
| Percentage of participants with undetectable HCV RNA at Day 15 | Day 15 | |
| Percentage of participants with undetectable HCV RNA at Day 28 |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23439365 | Result | Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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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| IDX184 200 mg QD + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
|
| IDX184 200 mg BID + Peg-IFN/RBV | Experimental | Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28. |
|
| Placebo | Drug | Placebo white opaque capsules taken by mouth from Day 1 to Day 14. |
|
| Peginterferon alfa-2a (Peg-IFN) | Biological | Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28. |
|
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| Ribavirin (RBV) | Drug | RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28. |
|
| Day 28 |
| Percentage of participants experiencing virologic breakthrough while on study therapy | Up to 28 days |
| Change in alanine aminotransferase (ALT) level from Baseline to Day 15 | Baseline and Day 15 |
| Change in ALT level from Baseline to Day 28 | Baseline and Day 28 |
| Maximum concentration (Cmax) | Up to 28 days |
| Time to maximum concentration (Tmax) | Up to 28 days |
| Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t) | Up to 28 days |
| AUC from time zero to infinity (AUC0-~) | Up to 28 days |
| Trough concentration (Ctrough) | Up to 28 days |
| Observed terminal half-life (Thalf) | Up to 28 days |
| D006525 |
| Hepatitis, Viral, Human |
| 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 |