Hepatitis C Infection
Conditions
Keywords
Antivirals
Brief summary
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
Interventions
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
DRUGribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
DRUGDaclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks
DRUGPlacebo
Tablet, oral, 0 mg, Daily 48 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients chronically infected with hepatitis C virus (HCV) genotype 1 * HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening * Treatment naive Key
Exclusion criteria
* Women of child-bearing potential * Cirrhosis * Coinfection with HIV or hepatitis B virus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 | A Weeks 4 and 12 | eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | At Week 4 | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4. |
| Percentage of Participants With Early Virologic Response (EVR) at Week 12 | At Week 12 | EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA \<10 IU/mL for participants with baseline HCV RNA \<1000 IU/mL. |
| Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | At Week 12 | cEVR was defined as hepatitis C virus RNA \<10 IU/mL at Week 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | From Day 31 up to Week 24 of post treatment follow-up | An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. |
| Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | From screening up to Week 12 (treatment period) | Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as \>5.0 to 10.0\* Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*ULN, Grade 4 as \>10.0\*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as \<7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749\*10\^9/L, Grade 4 as \<0.5\*10\^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499\*10\^9/L, Grade 4 as \<0.35\*10\^9/L; Total Bilirubin- Grade 3 as 2.6-5.0\*ULN, Grade 4 as \>5.0\*ULN; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L. |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug | An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. |
Countries
France, United States
Participant flow
Recruitment details
The study was conducted at 14 sites in France and USA.
Pre-assignment details
A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). | 12 |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). | 12 |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). | 12 |
| Placebo+pegIFNα-2a+Ribavirin Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). | 12 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 4 | 2 |
| Overall Study | Lack of Efficacy | 2 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 |
| Overall Study | Subject no Longer Meets Study Criteria | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin | Placebo+pegIFNα-2a+Ribavirin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 8.56 | 53.2 years STANDARD_DEVIATION 9.11 | 52 years STANDARD_DEVIATION 7.34 | 48 years STANDARD_DEVIATION 10.2 | 51.3 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 5 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 7 Participants | 8 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 12 / 12 | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 | 1 / 12 | 1 / 12 | 0 / 12 |
Outcome results
Primary
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Time frame: A Weeks 4 and 12
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 | 41.7 percentage of participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 | 83.3 percentage of participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 | 75 percentage of participants |
| Placebo + pegIFNα-2a + Ribavirin | Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 | 8.3 percentage of participants |
Secondary
Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
cEVR was defined as hepatitis C virus RNA \<10 IU/mL at Week 12
Time frame: At Week 12
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | 58.3 percentage of participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | 83.3 percentage of participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | 83.3 percentage of participants |
| Placebo + pegIFNα-2a + Ribavirin | Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | 41.7 percentage of participants |
Secondary
Percentage of Participants With Early Virologic Response (EVR) at Week 12
EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA \<10 IU/mL for participants with baseline HCV RNA \<1000 IU/mL.
Time frame: At Week 12
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Early Virologic Response (EVR) at Week 12 | 75 percentage of participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Early Virologic Response (EVR) at Week 12 | 100 percentage of participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Early Virologic Response (EVR) at Week 12 | 83.3 percentage of participants |
| Placebo + pegIFNα-2a + Ribavirin | Percentage of Participants With Early Virologic Response (EVR) at Week 12 | 66.7 percentage of participants |
Secondary
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
Time frame: At Week 4
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | 41.7 percentage of participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | 91.7 percentage of participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | 83.3 percentage of participants |
| Placebo + pegIFNα-2a + Ribavirin | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | 8.3 percentage of participants |
Other Pre-specified
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as \>5.0 to 10.0\* Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*ULN, Grade 4 as \>10.0\*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as \<7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749\*10\^9/L, Grade 4 as \<0.5\*10\^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499\*10\^9/L, Grade 4 as \<0.35\*10\^9/L; Total Bilirubin- Grade 3 as 2.6-5.0\*ULN, Grade 4 as \>5.0\*ULN; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L.
Time frame: From screening up to Week 12 (treatment period)
Population: All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin (n= 11,12,12,11) | 1 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes (n= 11,12,12,12) | 1 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils (n= 11,12,12,12) | 2 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Platelets (n= 11,12,12,12) | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT (n= 11,12,12,12) | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST (n= 11,12,12,12) | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin (n= 11,12,12,12) | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC (n= 11, 12, 12, 12) | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST (n= 11,12,12,12) | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT (n= 11,12,12,12) | 1 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes (n= 11,12,12,12) | 3 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC (n= 11, 12, 12, 12) | 2 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin (n= 11,12,12,12) | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Platelets (n= 11,12,12,12) | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils (n= 11,12,12,12) | 4 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin (n= 11,12,12,11) | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin (n= 11,12,12,12) | 1 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils (n= 11,12,12,12) | 3 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Platelets (n= 11,12,12,12) | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT (n= 11,12,12,12) | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST (n= 11,12,12,12) | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC (n= 11, 12, 12, 12) | 1 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin (n= 11,12,12,11) | 1 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes (n= 11,12,12,12) | 3 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils (n= 11,12,12,12) | 4 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Platelets (n= 11,12,12,12) | 1 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes (n= 11,12,12,12) | 3 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin (n= 11,12,12,11) | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT (n= 11,12,12,12) | 3 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC (n= 11, 12, 12, 12) | 2 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin (n= 11,12,12,12) | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST (n= 11,12,12,12) | 3 participants |
Other Pre-specified
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time frame: From Day 31 up to Week 24 of post treatment follow-up
Population: All participants who received at least 1 dose of study drug. n=evaluable patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | SAEs (n=10,12,12,10) | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Discontinuation due to AEs | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Grade 2 to 4 Related AEs | 0 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Deaths | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Discontinuation due to AEs | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Grade 2 to 4 Related AEs | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Deaths | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | SAEs (n=10,12,12,10) | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Grade 2 to 4 Related AEs | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Discontinuation due to AEs | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Deaths | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | SAEs (n=10,12,12,10) | 3 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Deaths | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Discontinuation due to AEs | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | SAEs (n=10,12,12,10) | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period | Grade 2 to 4 Related AEs | 0 participants |
Other Pre-specified
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time frame: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | SAEs | 1 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Discontinuation due to AEs | 1 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Grade 2 to 4 Related AEs | 6 participants |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Deaths | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Discontinuation due to AEs | 1 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Grade 2 to 4 Related AEs | 6 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Deaths | 0 participants |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | SAEs | 1 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Grade 2 to 4 Related AEs | 9 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Discontinuation due to AEs | 4 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Deaths | 0 participants |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | SAEs | 1 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Deaths | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Discontinuation due to AEs | 2 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | SAEs | 0 participants |
| Placebo + pegIFNα-2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase | Grade 2 to 4 Related AEs | 7 participants |