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| Name | Class |
|---|---|
| Santaris Pharma A/S | INDUSTRY |
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Population | Participants who previously received 12 weeks of miravirsen monotherapy in Study SPC3649-207 will complete up to 36 months of safety and efficacy follow-up without investigational treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 36 months | |
| Incidence of sustained virologic response (SVR) | 48 weeks after end of treatment (EOT) | |
| Change from Baseline in HCV ribonucleic acid (RNA) level | Up to 36 months | |
| Incidence of HCV resistance | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll null responders with CHC genotype 1 virus infection who have participated in Study SPC3649-207.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
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Blood and urine samples will be collected over a course of 7 study visits to obtain hematology, chemistry, urinalysis, coagulation, HCV RNA, and viral resistance data.
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| 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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