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| ID | Type | Description | Link |
|---|---|---|---|
| B3381001 |
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| Name | Class |
|---|---|
| ViroPharma | INDUSTRY |
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This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype
1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-Intron | Drug | SC injection, weight based dosing, weekly, 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis C Virus (HCV) RNA concentrations in the blood. | 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| REBETOL |
| Drug |
Capsules, weight based dosing, Q12 hrs daily, 48weeks |
|
| HCV 796 | Drug | Capsules, 500 mg, Q 12 hrs. daily, 48 weeks |
|
| Peg-Intron | Drug | SC injection, weight based dosing, weekly, 48 weeks |
|
| REBETOL | Drug | Capsules, weight based dosing, Q12 hrs daily, 48weeks |
|
| HCV 796 | Drug | Capsules, 500 mg, Q 12 hrs. daily, 48 weeks |
|
| Peg-Intron | Drug | SC injection, weight based dosing, weekly, 48 weeks |
|
| REBETOL | Drug | Capsules, weight based dosing, Q12 hrs daily, 48weeks |
|
| La Jolla |
| California |
| 92037 |
| United States |
| Pfizer Investigational Site | La Jolla | California | 92067 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | Pasadena | California | 91105 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Diego | California | 92161 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | San Francisco | California | 94121 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32610 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Plymouth | Minnesota | 55446 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55117 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63104 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | New York | New York | 10032 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10461 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10468 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7209 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19141 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Annandale | Virginia | 22003 | United States |
| Pfizer Investigational Site | Fairfax | Virginia | 22031 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23249 | United States |
| Pfizer Investigational Site | 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 |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| C539481 | HCV 796 |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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