Hepatitis C Clinical Trial
Official title:
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
| Status | Completed |
| Enrollment | 416 |
| Est. completion date | November 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - HCV RNA = 10,000 IU/mL at screening - Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNa, pegIFNa), RBV, or HCV DAA (protease, polymerase inhibitor, etc.) - Treatment-experienced subjects are eligible Exclusion Criteria: - Evidence of cirrhosis - Liver or any other organ transplant - Current or known history of cancer within 5 years prior to enrollment - Documented or suspected HCC - Evidence of decompensated liver |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution | Adelaide | South Australia |
| Australia | Local Institution | Clayton | |
| Australia | Local Institution | Darlinghurst | New South Wales |
| Australia | Local Institution | Fitzroy | Victoria |
| Australia | Local Institution | Fremantle | Western Australia |
| Australia | Local Institution | Greenslopes | Queensland |
| Australia | Local Institution | Heidelberg | Victoria |
| Canada | Local Institution | Calgary | Alberta |
| Canada | Local Institution | Hamilton | Ontario |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Vancouver | British Columbia |
| Canada | Local Institution | Victoria | British Columbia |
| France | Local Institution | Clichy | |
| France | Local Institution | Limoges Cedex | |
| France | Local Institution | Montpellier | |
| France | Local Institution | Paris Cedex 14 | |
| France | Local Institution | Pessac | |
| France | Local Institution | Vandoeuvre Les Nancy | |
| Puerto Rico | Fundacion De Investigacion De Diego | San Juan | |
| United States | Mt Vernon Endoscopy Center | Alexandria | Virginia |
| United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
| United States | Asheville Gastroenterology Associates, Pa | Asheville | North Carolina |
| United States | University Of Colorado Denver & Hospital | Aurora | Colorado |
| United States | Binghamton Gastroenterology Associates | Binghamton | New York |
| United States | James J Peters Vamc | Bronx | New York |
| United States | Digestive Disease Associates, P.A. | Catonsville | Maryland |
| United States | University Of Chicago Medical Center | Chicago | Illinois |
| United States | University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
| United States | Baylor St. Luke'S Medical Center | Houston | Texas |
| United States | Indiana University Med Center | Indianapolis | Indiana |
| United States | Borland-Groover Clinic | Jacksonville | Florida |
| United States | Kansas City Care Clinic | Kansas City | Missouri |
| United States | Kansas City Research Institute | Kansas City | Missouri |
| United States | Scripps Clinic | La Jolla | California |
| United States | Johns Hopkins Medical Institutions | Lutherville | Maryland |
| United States | Dean Clinic | Madison | Wisconsin |
| United States | Gastrointestinal Specialists Of Georgia | Marietta | Georgia |
| United States | Quality Medical Research Pllc | Nashville | Tennessee |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Bon Secours St. Mary'S Hospital Of Richmond, Inc. | Newport News | Virginia |
| United States | Digestive And Liver Disease Specialists | Norfolk | Virginia |
| United States | Henry Ford Health System | Novi | Michigan |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University Of Pittsburgh Medical Center, Ctr For Liver Diseases | Pittsburg | Pennsylvania |
| United States | Premier Medical Group Of The Hudson Valley, Pc | Poughkeepsie | New York |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Washington University School Of Medicine | Saint Louis | Missouri |
| United States | Texas Liver Institute | San Antonio | Texas |
| United States | Medical Associates Research Group | San Diego | California |
| United States | Quest Clinical Research | San Francisco | California |
| United States | Miami Research Associates | South Miami | Florida |
| United States | Carolinas Center For Liver Disease | Statesville | North Carolina |
| United States | Healthcare Research Consultants | Tulsa | Oklahoma |
| United States | Options Health Research, Llc | Tulsa | Oklahoma |
| United States | The Gastroenterology Group Of South Jersey | Vineland | New Jersey |
| United States | Trial Management Associates, Llc | Wilmington | North Carolina |
| United States | Digestive Health Specialists, Pa | Winston-salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Canada, France, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 | SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12 | Post-Treatment Week 12 | No |
| Secondary | Proportion of subjects in the experienced cohort with SVR12 | Follow up Week 12 | No | |
| Secondary | Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) | No | |
| Secondary | Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 | No | |
| Secondary | Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort | Up to post treatment week 4 (±7 days) | Yes | |
| Secondary | Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg =10 g/dL at baseline , in each cohort | Up to post treatment week 4 (±7 days) | Yes | |
| Secondary | Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort | Up to post treatment week 4 (±7 days) | Yes | |
| Secondary | Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b | Post treatment week 12 | No | |
| Secondary | Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) | Post treatment week 12 | No | |
| Secondary | Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis | Post treatment week 12 | No |
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