Clinical trial NCT01359644: Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Official title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pharmasset
First posted: 2011-05-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 to 70 years.
* Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
* Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

* Evidence of a medical condition associate with chronic liver disease other than HCV.
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
* History of hemophilia.
* History of torsade de pointes.
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
* History of gastrointestinal disease or surgical procedure (except cholecystectomy).
* History of clinically significant cardiac disease.
* Blood transfusion within 4 weeks prior to study drug administration.
* Poor venous access.
* Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
timeFrame: Follow-up Week 12
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
timeFrame: Follow-up Week 24
measure: Percentage of Participants With Viral Breakthrough During the Treatment Period
timeFrame: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
measure: Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
timeFrame: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
measure: Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
timeFrame: Baseline, Follow-up week 24
measure: Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
timeFrame: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
measure: Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
timeFrame: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Liver Centers
state: California
city: San Diego
country: United States
facility: Research And Education, Inc.
state: California
city: Aurora
country: United States
facility: University Of Colorado Denver & Hospital
state: Colorado
city: Gainesville
country: United States
facility: University Of Florida Hepatology
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University Of Michigan Health System
state: Michigan
city: Bronx
country: United States
facility: Bronx Va Medical Center 3c Sub-J
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.