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The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.
The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.
Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
|
| 2 | Experimental | ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
|
| 3 | Experimental | ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | oral BID |
| |
| ANA598 |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV RNA | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Throughout study | |
| Undetectable HCV RNA | Week 4, Week 24, and Week 48 | |
| ANA598, Peg-IFN-a-2-a, ribavirin concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, California 1 | Anaheim | California | 92801 | United States | ||
| United States, California 4 |
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| Drug |
oral 200mg BID |
|
| ANA598 | Drug | oral 400mg BID |
|
| Peginterferon | Drug | 180 μg dose via subcutaneous injection weekly |
|
| Ribavirin | Drug | oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg |
|
| Various time points through Week 12 |
| Undetectable HCV RNA | 24 weeks after completion of therapy for sustained virologic response [SVR] |
| Los Angeles |
| California |
| 90048 |
| United States |
| United States, California 2 | San Clemente | California | 92673 | United States |
| United States, California 3 | San Diego | California | 92120 | United States |
| United States, California 5 | San Francisco | California | 33136 | United States |
| United States, Florida 2 | Gainesville | Florida | 32601 | United States |
| United States, Florida 3 | Miami | Florida | 33136 | United States |
| United States, Florida 1 | Sarasota | Florida | 34209 | United States |
| United States, Maryland | Lutherville | Maryland | 21093 | United States |
| United States, Massachusetts | Boston | Massachusetts | 02215 | United States |
| United States, Michigan | Detroit | Michigan | 48202 | United States |
| United States, New York | New York | New York | 10021 | United States |
| United States, North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| United States, North Carolina | Durham | North Carolina | 27705 | United States |
| United States, Ohio | Cincinnati | Ohio | 45267 | United States |
| United States, Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| United States, Texas 2 | Houston | Texas | 77073 | United States |
| United States, Texas 1 | San Antonio | Texas | 78215 | United States |
| United States, Virginia 1 | Fairfax | Virginia | 22031 | United States |
| United States, Virginia 2 | Falls Church | Virginia | 22042 | United States |
| Puerto Rico | Santurce | 00909 | Puerto Rico |
| 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 |
|---|---|
| C000592794 | setrobuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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