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The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miravirsen sodium | Experimental |
| |
| Telaprevir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miravirsen sodium | Drug | Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax. | Up to 24 hours after dosing. | |
| Safety and tolerability of co-administered miravirsen and telaprevir. | Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax. | Up to 24 hours after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Rice, MD | Spaulding Clinical Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C581159 | miravirsen |
| C486464 | telaprevir |
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|
| Telaprevir | Drug | Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods. |
|
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |