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The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Tablet, Oral, 60 mg, once daily, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \ | Post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \ |
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Inclusion Criteria:
Compensated cirrhotics were capped at approximately 25%
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Liver & Digestive Specialists (Alds) | Montgomery | Alabama | 36116 | United States | ||
| Va Long Beach Healthcare System - 11 |
A total of 448 participants were enrolled, and 246 entered treatment period. Remaining 202 did not enter treatment period (29: withdrew consent, 17: lost to follow-up, 156: no longer met study criteria). As per protocol, any participant who discontinued the treatment period was still expected to enter the post-treatment follow-up period.
The study was conducted at 33 clinical sites in United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin | Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (up to 48 Weeks) |
|
Not provided
Not provided
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| Peg-Interferon Alfa-2a | Drug | Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response |
|
|
| Ribavirin | Drug | Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response |
|
|
| Post-treatment Week 12 |
| Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \ | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24 |
| Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24 |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort. | From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP]) |
| Long Beach |
| California |
| 90822 |
| United States |
| Axis Clinical Trials | Los Angeles | California | 90036 | United States |
| Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University Of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| Ucsd Antiviral Research Center (Avrc) | San Diego | California | 92103 | United States |
| Precision Research Institute, Llc | San Diego | California | 92115 | United States |
| Medical Associates Research Group, Inc | San Diego | California | 92123 | United States |
| Miami V.A. Healthcare System | Maimi | Florida | 33125 | United States |
| University Of Miami | Miami | Florida | 33136 | United States |
| Florida Hospital Transplant Center | Orlando | Florida | 32804 | United States |
| Infectious Disease Research Institute, Inc | Tampa | Florida | 33614 | United States |
| South Florida Center Of Gastroenterology, P.A. | Wellington | Florida | 33414 | United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | United States |
| Atlanta Medical Center | Atlanta | Georgia | 30312 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Digestive Health Center | Ocean Springs | Mississippi | 39564 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Liver Associates Of Texas | Houston | Texas | 77030 | United States |
| Research Specialists Of Texas | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Mcguire D V A M C | Richmond | Virginia | 23249 | United States |
| Local Institution | San Juan | 00927 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period (up to 48 Weeks) |
|
|
All treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin | Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Hepatitis C Virus RNA Levels | Mean | Standard Deviation | Log10 IU/mL |
| ||||||||||||||||||||||
| Hepatitis C Virus RNA Distribution | Number | participants |
| |||||||||||||||||||||||
| Hepatitis C Virus Genotype | Number | participants |
| |||||||||||||||||||||||
| rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \ | All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts. | Posted | Number | 95% Confidence Interval | percentage of participants | Post-treatment Week 12 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene | SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \ | All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Post-treatment Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \ | All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points | The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. | All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died | An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort. | All treated participants for TP and all follow-up participants for FUP. Here, "n" signifies the number of participants evaluable in their respective study periods. | Posted | Number | participants | From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP]) |
|
From first dose to 7 days post last dose of study treatment
On-treatment Period
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin | Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events. | 21 | 246 | 227 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BristolMyers Squibb Study Director | BristolMyers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Other |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| White Latino |
|
| White/Caucasian Non-Latino |
|
| Subtype 1 |
|
| Minor Homozygous (TT) |
|
| OG001 | Latino Cohort | Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants. |
| OG002 | White Non-Latino Cohort | Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. |
|
|
| OG001 | Latino Cohort | Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants. |
| OG002 | White Non-Latino Cohort | Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. |
|
|
| OG001 | Latino Cohort | Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants. |
| OG002 | White Non-Latino Cohort | Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. |
|
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| OG001 | White/Caucasian Cohort | Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants. |
| OG002 | Latino Cohort | Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants. |
| OG003 | Non-Latino Cohort | Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants. |
| OG004 | Overall Population | Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. |
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