Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharmasset | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: PSI-7977 + Daclatasvir | Experimental | Genotype 1a or 1b |
|
| Treatment B: PSI-7977 + Daclatasvir | Experimental | Genotype 2 or 3 |
|
| Treatment C: PSI-7977 + Daclatasvir | Experimental | Genotype 1a or 1b |
|
| Treatment D: PSI-7977 + Daclatasvir | Experimental | Genotype 2 or 3 |
|
| Treatment E: PSI-7977 + Daclatasvir + Ribavirin | Experimental | Genotype 1a or 1b |
|
| Treatment F: PSI-7977 + Daclatasvir+ Ribavirin | Experimental | Genotype 2 or 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSI-7977 | Drug | Tablets, oral, 400 mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir. | Follow-up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir. | Follow-up Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Liver Centers | Coronado | California | 92118 | United States | ||
| Research And Education, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24428467 | Derived | 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. |
Not provided
Not provided
A total of 350 participants were enrolled, and 211 were randomized and received study drug.
The study was conducted at 18 centres in 2 countries.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A: Sofosbuvir + Daclatasvir | Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks. |
| FG001 | Treatment B: Sofosbuvir + Daclatasvir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Treatment G: PSI-7977 + Daclatasvir | Experimental | Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b |
|
| Treatment H: PSI-7977 + BMS-790052 + Ribavirin | Experimental | Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b |
|
| Treatment I: PSI-7977 + Daclatasvir | Experimental | Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b |
|
| Treatment J: PSI-7977 + Daclatasvir + Ribavirin | Experimental | Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b |
|
| Daclatasvir | Drug | Tablets, oral, 60 mg, once daily |
|
|
| Ribavirin | Drug | Tablets, oral, 200 mg |
|
|
| Percentage of Participants With Viral Breakthrough During the Treatment Period |
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8. |
| First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group) |
| Percentage of Participants Who Experienced Viral Relapse During Follow-up Period | Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment. | Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks) |
| Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 | Change from baseline in log10 HCV RNA at scheduled sampling time. | Baseline, Follow-up week 24 |
| 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 | 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe. | First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group) |
| 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 | 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe | 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) |
| San Diego |
| California |
| 92105 |
| United States |
| University Of Colorado Denver & Hospital | Aurora | Colorado | 80045 | United States |
| University Of Florida Hepatology | Gainesville | Florida | 32610 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| University Of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Bronx Va Medical Center 3c Sub-J | The Bronx | New York | 10468 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | San Juan | 00927 | Puerto Rico |
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks. |
| FG002 | Treatment C: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. |
| FG003 | Treatment D: Sofosbuvir + Daclatasvir | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. |
| FG004 | Treatment E: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks. |
| FG005 | Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks. |
| FG006 | Treatment G: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks. |
| FG007 | Treatment H : Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks. |
| FG008 | Treatment I: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. |
| FG009 | Treatment J: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A: Sofosbuvir + Daclatasvir | Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks. |
| BG001 | Treatment: Sofosbuvir + Daclatasvir | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks. |
| BG002 | Treatment C: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. |
| BG003 | Treatment D: Sofosbuvir + Daclatasvir | Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.. |
| BG004 | Treatment E: Sofosbuvir +Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks. |
| BG005 | Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks. |
| BG006 | Treatment G: Sofosbuvir + Daclatasvir | Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.. |
| BG007 | Treatment H: Sofosbuvir +Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks. |
| BG008 | Treatment I: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks. |
| BG009 | Treatment J: Sofosbuvir +Daclatasvir +Ribavirin | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks. |
| BG010 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | Percentage of participants | Follow-up Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | Percentage of participants | Follow-up Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough During the Treatment Period | Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | Percentage of participants | First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Viral Relapse During Follow-up Period | Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Number | Percentage of participants | Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 | Change from baseline in log10 HCV RNA at scheduled sampling time. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | Mean | Standard Deviation | IU/mL | Baseline, Follow-up week 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe. | All participants who received at least 1 dose of study drug. | Posted | Number | Participants | First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe | All participants who received at least 1 dose of study drug and entered follow-up period | Posted | Number | Participants | 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) |
|
Not provided
Not provided
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 | Treatment A: Sofosbuvir + Daclatasvir | Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks. | 2 | 15 | 0 | 15 | ||
| EG001 | Treatment B: Sofosbuvir + Daclatasvir | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks | 0 | 16 | 0 | 16 | ||
| EG002 | Treatment C: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. | 2 | 14 | 0 | 14 | ||
| EG003 | Treatment D: Sofosbuvir + Daclatasvir | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. | 3 | 14 | 0 | 14 | ||
| EG004 | Treatment E: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks. | 2 | 15 | 0 | 15 | ||
| EG005 | Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks | 2 | 14 | 0 | 14 | ||
| EG006 | Treatment G: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks. | 1 | 41 | 0 | 41 | ||
| EG007 | Treatment H : Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks. | 1 | 41 | 0 | 41 | ||
| EG008 | Treatment I: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks. | 0 | 21 | 0 | 21 | ||
| EG009 | Treatment J: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks. | 2 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
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 | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Trials@bms.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| >= 65 years |
|
| Male |
|
|
| DCF/SOF All |
|
| Telaprevir/Boceprevir Failures With Genotype 1 |
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks. |
|
|
| OG002 |
| Telaprevir or Boceprevir Failures With Genotype 1 |
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks. |
|
|
| OG002 | Telaprevir or Boceprevir Failures With Genotype 1 | Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks. |
|
|
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
| OG004 | Treatment E: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks. |
| OG005 | Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks. |
| OG006 | Treatment G: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks. |
| OG007 | Treatment H: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks. |
| OG008 | Treatment I: Sofosbuvir + Daclatasvir | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks. |
| OG009 | Treatment J: Sofosbuvir + Daclatasvir + Ribavirin | Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks. |
|
|
| OG002 | Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks. |
| OG003 | Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks. |
|
|
Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks. |
| OG002 | Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks. |
| OG003 | Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks. |
|
|