Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1
2 other identifiers
interventional
215
3 countries
18
Brief Summary
The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedOctober 9, 2015
September 1, 2015
2.8 years
November 12, 2009
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment
12 weeks post treatment
Secondary Outcomes (5)
Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results
12 weeks post-treatment
Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Day 1 and Day 14
Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16
Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Day 1 and Day 14
Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Day 1 and Day 14
Study Arms (7)
Arm 1: Sentinel A
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
Arm 2: Sentinel B
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Arm 3: Expansion A1
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
Arm 4: Expansion A2
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
Arm 5: Expansion B1
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Arm 6: Expansion B2
EXPERIMENTALBMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
Arm 7: Expansion B3
EXPERIMENTALBMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
Interventions
Tablets, Oral, 60 mg, once daily, 24 weeks
Syringe, Subcutaneous Injection, 180 µg, once weekly
Tablets, Oral For subjects weighing \< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks
Eligibility Criteria
You may qualify if:
- Male and female subjects ages 18 to 70 years
- HCV-Infected Genotype 1 Null responders to current standard of care
- Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.
You may not qualify if:
- 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 Cancer within 5 years of enrollment
- History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
- History of clinically significant cardiac disease
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Documented cirrhosis within 12 months prior to dosing
- Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Southern California Liver Centers
Coronado, California, 92118, United States
San Jose Gastroenterology
San Jose, California, 95128, United States
University Of Colorado Denver & Hospital
Aurora, Colorado, 80045, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
University Of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, 76012, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Local Institution
Clichy, 92118, France
Local Institution
Créteil, 94010, France
Local Institution
Marseille, 13285, France
Local Institution
Paris, 75571, France
Local Institution
Paris, 75651, France
Local Institution
Paris, 75679, France
Local Institution
Pessac, 33604, France
Local Institution
San Juan, 00927, Puerto Rico
Related Publications (3)
Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
PMID: 26683763DERIVEDMcPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.
PMID: 23504694DERIVEDLok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.
PMID: 22256805DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
December 1, 2009
Primary Completion
October 1, 2012
Study Completion
February 1, 2014
Last Updated
October 9, 2015
Record last verified: 2015-09