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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003103-35 | EudraCT Number |
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To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BZF961 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BZF961 | Drug | There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses. |
| Measure | Description | Time Frame |
|---|---|---|
| HCV viral load | Viral load samples will be taken at Day 3. | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety | 2 weeks | |
| Total BZF961 concentration in plasma | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects that were previously treated for HCV infection.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Diego | California | 92120 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CBZF9612201 from the Novartis Clinical Trials website | View source |
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| Ritonavir | Drug | Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961 |
|
| Placebo | Drug | Placebo |
|
| Orlando |
| Florida |
| 32809 |
| United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| 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 |
|---|---|
| C000634526 | BZF961 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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