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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001841-25 | EudraCT Number |
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This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid [RNA]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOC/PR | Active Comparator | All participants begin treatment with a 4-week lead-in of PR followed by 24 weeks of BOC/PR. At Treatment Week (TW) 28 TN participants who have undetectable HCV RNA at TW 8 will complete BOC/PR therapy. At TW 28 TN participants who have detectable HCV RNA at TW 8, as well as prior relapsers and prior partial responders, will continue on BOC/PR for an additional 8 weeks and then continue on PR for an additional 12 weeks. At TW 28 all cirrhotics and previous null responders will continue on BOC/PR for an additional 20 weeks. |
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| Grazoprevir/Elbasvir | Experimental | Participants will undergo treatment with grazoprevir 100 mg + elbasvir 50 mg for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir/Elbasvir | Drug | Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO). |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving SVR12 | Up to Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of TN participants achieving SVR12 | Up to Week 60 | |
| Number of participants experiencing an adverse event (AE) | Up to Week 72 | |
| Number of participants withdrawing from study treatment due to AEs |
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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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| Boceprevir | Drug | Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO. |
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| PegIntron | Drug | Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection. |
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| Ribavarin | Drug | Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO. |
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| Up to Week 72 |
| Proportion of PTF participants achieving SVR12 | Up to Week 60 |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C417083 | peginterferon alfa-2b |
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