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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin | Active Comparator | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination |
|
| PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin | Active Comparator | PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination |
|
| PPI-668, BI 207127 Dose 1, and Faldaprevir | Active Comparator | PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI-668 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients achieving sustained viral response (SVR) | 12 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with "virologic relapse" post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment | up to 24 weeks post-treatment | |
| Proportion of patients with confirmed viral breakthrough during study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Brown, MD | Presidio Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Clinical Research | San Francisco | California | 94115 | United States |
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| BI 207127 Dose 1 | Drug |
|
| BI 207127 Dose 2 | Drug |
|
| Faldaprevir | Drug |
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| Ribavirin | Drug |
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| BI 207127 Placebo | Drug |
|
"Confirmed viral breakthrough" is defined as a > 1 log increase in HCV RNA from post-Baseline nadir value or confirmed increase in HCV RNA ≥LLOQ if HCV RNA previously declined to \ |
| up to 12 weeks of study treatment |
| Proportions of study participants who receive at least one dose of study drug and who prematurely discontinue study treatment, and proportions prematurely discontinuing treatment for clinical adverse events or laboratory abnormalities | up to 12 weeks of study treatment |
| Proportions of study participants experiencing treatment-emergent adverse events (serious and non-serious) considered to be possibly or probably attributable to study treatment, overall and by body system | up to 12 weeks of study treatment |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| 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 |
|---|---|
| C000621711 | ravidasvir |
| C552340 | faldaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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