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| ID | Type | Description | Link |
|---|---|---|---|
| IDX-06A-005 | Other Identifier | Idenix Protocol Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants.
Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV | Experimental | Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
|
| Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV | Experimental | Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
|
| Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV | Experimental | Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
|
| Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV | Experimental | Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samatasvir | Drug | Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced an adverse event (AE) | Up to approximately 95 weeks | |
| Percentage of participants who experienced a serious adverse event (SAE) | Up to approximately 95 weeks | |
| Percentage of participants who experienced a Grade 1-4 laboratory abnormality | Up to 66 weeks | |
| Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4) | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced rapid virologic response (RVR) | Week 4 | |
| Percentage of participants who experienced early virologic response (EVR) | Week 12 | |
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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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| Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV | Experimental | Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
|
| Part B: GT 6 - samatasvir 100/simeprevir/RBV | Experimental | Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
|
| Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV | Experimental | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks |
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| Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV | Experimental | Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks |
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| Simeprevir | Drug | Simeprevir will be supplied as 75 and 150 mg oral capsules. |
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| Ribavirin (RBV) | Drug | Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
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| TMC647055 | Drug | TMC647055 will be supplied as 150 mg oral capsules. |
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| Ritonavir (RTV) | Drug | Ritonavir will be supplied as 80 mg/mL oral solution. |
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| Pegylated interferon (Peg-IFN) | Biological | Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment. |
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| Samatasvir matching placebo | Other | Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A. |
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| Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8) |
| Up to 20 weeks |
| Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12) | Up to 24 weeks |
| Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24) | Up to 36 weeks |
| Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t | Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84 |
| Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax) | Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84 |
| Pharmacokinetic Parameter: Trough drug concentration (Ctrough) | Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C000597389 | samatasvir |
| D000069616 | Simeprevir |
| D012254 | Ribavirin |
| C575713 | 27-cyclohexyl-12,13,16,17-tetrahydro-22-methoxy-11,17-dimethyl-10,10-dioxide-2,19-methano-3,7:4,1-dimetheno-1H,11H-14,10,2,9,11,17-benzoxathiatetraazacyclo docosine-8,18(9H,15H)-dione |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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