Back to resultsStudy to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-650032
BMS-790052
BMS-791325
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Men and women, ages ≥18 years of age
- Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
Subjects should have chronic hepatitis C (CHC) as documented by:
- Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
- Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
- HCV genotype 1a, 1b or 4 only
- HCV RNA viral load of ≥10,000 IU/mL at screening
Have one of the following:
- Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
- Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
- Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
- Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
- Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening
Exclusion Criteria:
- Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
- 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
- Documented or suspected hepatocellular carcinoma (HCC)
- Positive for hepatitis B surface antigen (HBsAg)
- Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
- Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)
- Total Bilirubin ≥2 mg/dL
Sites / Locations
- The Kirklin Clinic
- Southern California Research Center
- Peter J Ruane Md Inc
- Va Greater Los Angeles Healthcare System
- Research And Education, Inc.
- Precision Research Institute, Llc
- Medical Associates Research Group
- University Of Colorado Denver And Hospital
- Medstar Georgetown University Hospital
- Orlando Immunology Center
- Miami Research Associates
- Atlanta Gastroenterology Associates, Llc
- Mercy Medical Center, Inc.
- Johns Hopkins University
- Id Care
- Southwest Care Center
- James J Peters Vamc
- Options Health Research, Llc
- Healthcare Research Consultants
- Texas Clinical Research Institute
- Research Specialists Of Texas
- Alamo Medical Research
- Lifetree Clinical Research
- Metropolitan Research
- Inova Fairfax Hospital
- Dean Clinic
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Fundacion De Investigacion De Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV
Arm Description
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 60 mg tablet by mouth once daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2 BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 60 mg tablet by mouth once daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
* Genotype 4 treatment-naive subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 75 mg table by mouth twice daily for 12 Weeks
* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks BMS 791325 150 mg table by mouth twice daily for 12 Weeks
* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 75 mg table by mouth twice daily for 24 Weeks
* Genotype 1 treatment-null/non-responder subjects BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks BMS 791325 150 mg table by mouth twice daily for 24 Weeks
* Genotype 1 treatment-naive subjects BMS-650032 200 mg tablets orally twice daily 12 weeks BMS-790052 30 mg tablets orally twice daily 12 weeks BMS-791325 75 mg tablets orally twice daily 12 weeks Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks [if subject is < 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM]
Outcomes
Primary Outcome Measures
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
Secondary Outcome Measures
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
Proportion of subjects who experience viral breakthrough
viral breakthrough defined as:
Any increase in HCV RNA ≥ 1 log10 from nadir or
Any quantifiable HCV RNA ≥ 25 IU/mL (> LOQ) on or after Week 8
Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)
Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01455090
Brief Title
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
Official Title
Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2011 (Actual)
Primary Completion Date
March 31, 2014 (Actual)
Study Completion Date
July 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin
Detailed Description
IND numbers: 79,599; 101,943
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 60 mg tablet by mouth once daily for 24 Weeks
BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Arm Title
Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 60 mg tablet by mouth once daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 60 mg tablet by mouth once daily for 24 Weeks
BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Arm Title
Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 60 mg tablet by mouth once daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
* Genotype 4 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Genotype 4 treatment-naive subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Arm Title
Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Arm Title
Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks
BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Arm Title
Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks
BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Arm Title
Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-null/non-responder subjects
BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks
BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks
BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Arm Title
Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV
Arm Type
Experimental
Arm Description
* Genotype 1 treatment-naive subjects
BMS-650032 200 mg tablets orally twice daily 12 weeks
BMS-790052 30 mg tablets orally twice daily 12 weeks
BMS-791325 75 mg tablets orally twice daily 12 weeks
Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks [if subject is < 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM]
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Other Intervention Name(s)
Asunaprevir (ASV)
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Other Intervention Name(s)
Daclatasvir (DCV)
Intervention Type
Drug
Intervention Name(s)
BMS-791325
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
Time Frame
12 weeks post-treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Time Frame
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Title
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
Time Frame
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Title
Proportion of subjects who experience viral breakthrough
Description
viral breakthrough defined as:
Any increase in HCV RNA ≥ 1 log10 from nadir or
Any quantifiable HCV RNA ≥ 25 IU/mL (> LOQ) on or after Week 8
Time Frame
Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)
Title
Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)
Time Frame
End of treatment (Maximum up to 24 Weeks)
Title
Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Time Frame
Day 1 and Day 14
Title
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
Time Frame
At the time of viral breakthrough or relapse
Title
Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities
Time Frame
Formal analysis at week 48 of follow up period (or upon occurrence)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, ages ≥18 years of age
Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
Subjects should have chronic hepatitis C (CHC) as documented by:
Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
HCV genotype 1a, 1b or 4 only
HCV RNA viral load of ≥10,000 IU/mL at screening
Have one of the following:
Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening
Exclusion Criteria:
Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
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
Documented or suspected hepatocellular carcinoma (HCC)
Positive for hepatitis B surface antigen (HBsAg)
Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)
Total Bilirubin ≥2 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Peter J Ruane Md Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Va Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Research And Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Precision Research Institute, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University Of Colorado Denver And Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Atlanta Gastroenterology Associates, Llc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Mercy Medical Center, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Id Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Southwest Care Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
James J Peters Vamc
City
The Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Options Health Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Research Specialists Of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Dean Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
9410
Country
France
Facility Name
Local Institution
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Local Institution
City
Marseille Cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Fundacion De Investigacion De Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
26473667
Citation
Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir +/- ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.
Results Reference
derived
PubMed Identifier
24184132
Citation
Everson GT, Sims KD, Rodriguez-Torres M, Hezode C, Lawitz E, Bourliere M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
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