Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Registration Number
- NCT01428063
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
- Detailed Description
* Intervention Model:
* Parallel: for all patients entering the trial
* Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
* Peginterferon alfa-2a
* Ribavirin
* Daclatasvir
* Asunaprevir
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
- Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
- HCV RNA viral load detectable
Key
- Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
- Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV infection
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin Daclatasvir Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin Asunaprevir Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + PegIFNα-2a + Ribavirin Daclatasvir Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + PegIFNα-2a + Ribavirin Pegylated interferon alfa-2a Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin Pegylated interferon alfa-2a Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin Ribavirin Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + PegIFNα-2a + Ribavirin Ribavirin Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks Daclatasvir + Asunaprevir Daclatasvir Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks Daclatasvir + Asunaprevir Asunaprevir Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) Week 12 (Follow-up period) SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.
- Secondary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) Week 12 (Follow-up period) SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 Week 4 RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.
Percentage of Participants With Extended Rapid Virologic Response (eRVR) Week 4 and 12 eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.
Percentage of Participants With Complete Early Virologic Response (cEVR) Week 12 cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.
Percentage of Participants With End of the Treatment Response (EOTR) End of the study (Week 24) EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) Week 24 (Follow-up) SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Related Research Topics
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Trial Locations
- Locations (21)
Scpmg/ Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Medical Center South
🇺🇸Montgomery, Alabama, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Uf Hepatology Research At Ctrb
🇺🇸Gainesville, Florida, United States
Digestive Disease Associates, P.A.
🇺🇸Catonsville, Maryland, United States
Washington University School Of Medicine
🇺🇸St. Louis, Missouri, United States
Options Health Research, Llc
🇺🇸Tulsa, Oklahoma, United States
North Shore Long Island Jewish Health System
🇺🇸Manhasset, New York, United States
Local Institution
🇬🇧Glasgow, Lanarkshire, United Kingdom
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
University Of Colorado Denver And Hospital
🇺🇸Aurora, Colorado, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Schiff Center For Liver Diseases
🇺🇸Miami, Florida, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States