Study in Genotype 2 or 3 Patients With Chronic Hepatitis... | NCT01257204 | Trialant
NCT01257204
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Dec 14, 2015Estimated
Enrollment
196Actual
Phase
Phase 2
Conditions
Hepatitis C Virus
Interventions
Placebo
Daclatasvir
Pegylated interferon alfa-2a
Ribavirin
Countries
United States
Australia
Canada
Denmark
France
Italy
Protocol Section
Identification Module
NCT ID
NCT01257204
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AI444-031
Secondary IDs
ID
Type
Description
Link
2010-022408-28
EudraCT Number
Brief Title
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Official Title
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2010
Primary Completion Date
May 2012Actual
Completion Date
Sep 2012Actual
First Submitted Date
Dec 1, 2010
First Submission Date that Met QC Criteria
Dec 8, 2010
First Posted Date
Dec 9, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 5, 2015
Results First Submitted that Met QC Criteria
Nov 10, 2015
Results First Posted Date
Dec 14, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 10, 2015
Last Update Posted Date
Dec 14, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
SVR24 was defined as undetectable HCV RNA (HCV RNA \
Follow-up Week 24
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
SVR24 was defined as undetectable HCV RNA (HCV RNA \
Follow-up Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
RVR was defined as undetectable HCV RNA (HCV RNA \
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
Males and females, 18 - 70 years of age
Key Exclusion Criteria:
Liver transplant recipients
Documented or suspected hepatocellular carcinoma
Evidence of decompensated cirrhosis
History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
Current or known history of cancer
Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
Inability to tolerate oral medication
Poor venous access
Severe psychiatric disease
History of chronic pulmonary disease
History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
History of or current electrocardiogram findings indicative of cardiovascular instability
Preexisting ophthalmologic disorders considered clinically significant on eye
History of uncontrolled diabetes mellitus
Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 196 participants were enrolled, of which 152 participants were randomized; remaining 44 participants did not meet study criteria. Of randomized participants:151 were treated; 1 participant withdrew consent.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
FG001
Periods
Title
Milestones
Reasons Not Completed
Treatment Period (up to Week 24)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Daclatasvir
Drug
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
12 Week Cohort
16 Week Cohort
BMS-790052
Pegylated interferon alfa-2a
Drug
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
12 Week Cohort
16 Week Cohort
Control
Pegasys®
Ribavirin
Drug
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
12 Week Cohort
16 Week Cohort
Control
Copegus®
Week 4
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
RVR was defined as undetectable HCV RNA (HCV RNA \
Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
cEVR was defined as undetectable HCV RNA (HCV RNA \
Week 12
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
cEVR was defined as undetectable HCV RNA (HCV RNA \
Week 12
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
SVR12 was defined as undetectable HCV RNA (HCV RNA \
Follow-up Week 12
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
SVR12 was defined as undetectable HCV RNA (HCV RNA \
Follow-up Week 12
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \
Baseline up to Week 48
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \
Baseline up to Week 48
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
Baseline (Day 1) up to 24 weeks (treatment period)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has 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.
From end of treatment period up to Week 48 (follow-up period)
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
FG002
Placebo
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
FG00050 subjects
FG00150 subjects
FG00251 subjects
COMPLETED
FG00045 subjects
FG00144 subjects
FG00242 subjects
NOT COMPLETED
FG0005 subjects
FG0016 subjects
FG0029 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0023 subjects
Adverse Event
FG0003 subjects
FG0011 subjects
FG0022 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
Poor compliance/noncompliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
Participant's request to discontinue
FG0001 subjects
FG0012 subjects
FG0022 subjects
Follow-up Period (up to Week 48)
Type
Comment
Milestone Data
STARTED
FG00049 subjectsThose who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.
FG00147 subjectsThose who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.
FG00249 subjectsThose who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.
COMPLETED
FG00048 subjects
FG00141 subjects
FG00239 subjects
NOT COMPLETED
FG0001 subjects
FG0016 subjects
FG00210 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0021 subjects
Lost to Follow-up
FG000
All participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dacalatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
BG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
BG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00150
BG00251
BG003151
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.5± 8.42
BG00147.5± 9.20
BG00248.8± 9.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00113
BG002
Hepatitis C Virus (HCV) RNA (IU/mL)
Mean
Standard Deviation
Log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.4± 0.82
BG0016.6± 0.62
BG002
HCV RNA Distribution
Number
participants
Title
Denominators
Categories
<800,000 IU/mL
Title
Measurements
BG00012
BG0017
BG002
Randomization Stratum
Number
participants
Title
Denominators
Categories
HCV Genotype 2
Title
Measurements
BG00024
BG00123
BG002
Cirrhosis Status
Number
participants
Title
Denominators
Categories
Absent
Title
Measurements
BG00043
BG00143
BG002
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 Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
SVR24 was defined as undetectable HCV RNA (HCV RNA \
All treated participants with hepatitis C virus genotype 2.
Posted
Number
80% Confidence Interval
percentage of participants
Follow-up Week 24
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Units
Counts
Participants
OG00024
OG00123
OG00224
Title
Denominators
Categories
Title
Measurements
OG00083.3(73.6 to 93.1)
OG00182.6(72.5 to 92.7)
OG00262.5(49.8 to 75.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference
20.8
2-Sided
80
4.9
36.8
The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
No
Superiority or Other
OG001
OG002
Secondary
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
RVR was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 2.
Posted
Number
80% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
RVR was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 3.
Posted
Number
80% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
cEVR was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 2.
Posted
Number
80% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
cEVR was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 3.
Posted
Number
80% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Dacalatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
SVR12 was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 2.
Posted
Number
80% Confidence Interval
percentage of participants
Follow-up Week 12
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
SVR12 was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 3.
Posted
Number
80% Confidence Interval
percentage of participants
Follow-up Week 12
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \
All treated participants with HCV genotype 2. Here, "n" signifies the number of participants evaluable for the respective category.
Posted
Number
participants
Baseline up to Week 48
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Secondary
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \
All treated participants with HCV genotype 3. Here, "n" signifies the number of participants evaluable for the respective category.
Posted
Number
participants
Baseline up to Week 48
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Primary
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
SVR24 was defined as undetectable HCV RNA (HCV RNA \
All treated participants with HCV genotype 3.
Posted
Number
80% Confidence Interval
percentage of participants
Follow-up Week 24
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
All treated participants.
Posted
Number
participants
Baseline (Day 1) up to 24 weeks (treatment period)
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
OG001
Daclatasvir, 60 mg, 16-Week Cohort
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has 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.
All follow-up participants.
Posted
Number
participants
From end of treatment period up to Week 48 (follow-up period)
ID
Title
Description
OG000
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
OG001
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
Time Frame
Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Daclatasvir, 60 mg, 12-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
4
50
49
50
EG001
Daclatasvir, 60 mg, 16-Week Cohort
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
0
50
49
50
EG002
Placebo
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
3
51
48
51
EG003
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
2
49
0
49
EG004
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
0
47
0
47
EG005
Placebo: Follow-up
Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
0
49
0
49
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG0030 affected49 at risk
EG0040 affected47 at risk
EG0050 affected49 at risk
Biliary colic
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Rectal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Adhesion
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Appendiceal Abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Tonsil Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0007 affected50 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG0030 affected49 at risk
EG0040 affected47 at risk
EG0050 affected49 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0013 affected50 at risk
EG0028 affected51 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0013 affected50 at risk
EG0021 affected51 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0015 affected50 at risk
EG0023 affected51 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0009 affected50 at risk
EG0015 affected50 at risk
EG00211 affected51 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0013 affected50 at risk
EG0022 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0017 affected50 at risk
EG0026 affected51 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0013 affected50 at risk
EG0022 affected51 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG00014 affected50 at risk
EG00113 affected50 at risk
EG00214 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0014 affected50 at risk
EG0026 affected51 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected50 at risk
EG0024 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0004 affected50 at risk
EG0013 affected50 at risk
EG0028 affected51 at risk
EG003
Influenza like illness
General disorders
MedDRA 15.0
Systematic Assessment
EG00010 affected50 at risk
EG0019 affected50 at risk
EG0027 affected51 at risk
EG003
Injection site reaction
General disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0012 affected50 at risk
EG0023 affected51 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected50 at risk
EG0024 affected51 at risk
EG003
Asthenia
General disorders
MedDRA 15.0
Systematic Assessment
EG0006 affected50 at risk
EG0017 affected50 at risk
EG0027 affected51 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0004 affected50 at risk
EG0017 affected50 at risk
EG0029 affected51 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG00023 affected50 at risk
EG00112 affected50 at risk
EG00219 affected51 at risk
EG003
Injection site erythema
General disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0015 affected50 at risk
EG0021 affected51 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG00011 affected50 at risk
EG0018 affected50 at risk
EG00217 affected51 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0012 affected50 at risk
EG0023 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0012 affected50 at risk
EG0024 affected51 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0007 affected50 at risk
EG0015 affected50 at risk
EG0025 affected51 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0004 affected50 at risk
EG0013 affected50 at risk
EG0025 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0010 affected50 at risk
EG0024 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0016 affected50 at risk
EG0029 affected51 at risk
EG003
Chills
General disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0015 affected50 at risk
EG0023 affected51 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0014 affected50 at risk
EG0021 affected51 at risk
EG003
Irritability
General disorders
MedDRA 15.0
Systematic Assessment
EG0008 affected50 at risk
EG0019 affected50 at risk
EG0026 affected51 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG00010 affected50 at risk
EG00112 affected50 at risk
EG0028 affected51 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected50 at risk
EG0013 affected50 at risk
EG0020 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0012 affected50 at risk
EG0022 affected51 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0004 affected50 at risk
EG0018 affected50 at risk
EG0028 affected51 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected50 at risk
EG00111 affected50 at risk
EG0026 affected51 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected50 at risk
EG0013 affected50 at risk
EG0020 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG00015 affected50 at risk
EG00115 affected50 at risk
EG0029 affected51 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG00013 affected50 at risk
EG00112 affected50 at risk
EG00212 affected51 at risk
EG003
Vision blurred
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0003 affected50 at risk
EG0011 affected50 at risk
EG0022 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0005 affected50 at risk
EG0012 affected50 at risk
EG0026 affected51 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Clinical.Trials@bms.com
ID
Term
D006526
Hepatitis C
Ancestor Terms
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
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C549273
daclatasvir
C100416
peginterferon alfa-2a
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0014 subjects
FG0024 subjects
Other
FG0000 subjects
FG0010 subjects
FG0025 subjects
47.9
± 9.09
24
BG00355
Male
BG00032
BG00137
BG00227
BG00396
6.6
± 0.59
BG0036.5± 0.69
6
BG00325
≥800,000 IU/mL
Title
Measurements
BG00038
BG00143
BG00245
BG003126
24
BG00371
HCV Genotype 3
Title
Measurements
BG00026
BG00127
BG00227
BG00380
41
BG003127
Present
Title
Measurements
BG0007
BG0014
BG0028
BG00319
Not Reported
Title
Measurements
BG0000
BG0013
BG0022
BG0035
Difference
20.1
2-Sided
80
3.9
36.3
The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
No
Superiority or Other
Units
Counts
Participants
OG00024
OG00123
OG00224
Title
Denominators
Categories
Title
Measurements
OG00087.5(78.8 to 96.2)
OG00173.9(62.2 to 85.6)
OG00241.7(28.8 to 54.6)
Units
Counts
Participants
OG00026
OG00127
OG00227
Title
Denominators
Categories
Title
Measurements
OG00084.6(75.5 to 93.7)
OG00174.1(63.3 to 84.9)
OG00237.0(25.1 to 48.9)
Units
Counts
Participants
OG00024
OG00123
OG00224
Title
Denominators
Categories
Title
Measurements
OG00091.7(84.4 to 98.9)
OG00182.6(72.5 to 92.7)
OG00275.0(63.7 to 86.3)
Units
Counts
Participants
OG00026
OG00127
OG00227
Title
Denominators
Categories
Title
Measurements
OG00080.8(70.9 to 90.7)
OG00188.9(81.1 to 96.6)
OG00259.3(47.1 to 71.4)
Units
Counts
Participants
OG00024
OG00123
OG00224
Title
Denominators
Categories
Title
Measurements
OG00087.5(78.8 to 96.2)
OG00182.6(72.5 to 92.7)
OG00270.8(58.9 to 82.7)
Units
Counts
Participants
OG00026
OG00127
OG00227
Title
Denominators
Categories
Title
Measurements
OG00069.2(57.6 to 80.8)
OG00177.8(67.5 to 88.0)
OG00251.9(39.5 to 64.2)
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Units
Counts
Participants
OG00024
OG00123
OG00224
Title
Denominators
Categories
Virologic breakthrough (n=24,23,24)
Title
Measurements
OG0000
OG0011
OG0021
<1 log10 decrease in HCV RNA at Week4 (n=24,23,24)
Title
Measurements
OG0000
OG0011
OG0020
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=24,23,24)
Title
Measurements
OG0001
OG0012
OG0021
Relapse (n=23,21,22)
Title
Measurements
OG0001
OG0010
OG0022
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Units
Counts
Participants
OG00026
OG00127
OG00227
Title
Denominators
Categories
Virologic breakthrough (n=26,27,27)
Title
Measurements
OG0000
OG0010
OG0021
<1 log10 decrease in HCV RNA at Week4 (n=26,27,27)
Title
Measurements
OG0000
OG0011
OG0023
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=26,27,27)
Title
Measurements
OG0001
OG0012
OG0023
Relapse (n=25,24,21)
Title
Measurements
OG0006
OG0016
OG0023
Units
Counts
Participants
OG00026
OG00127
OG00227
Title
Denominators
Categories
Title
Measurements
OG00069.2(57.6 to 80.8)
OG00166.7(55.0 to 78.3)
OG00259.3(47.1 to 71.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference
10.0
2-Sided
80
-6.8
26.7
The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
No
Superiority or Other
OG001
OG002
Difference
7.4
2-Sided
80
-9.4
24.2
The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
No
Superiority or Other
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
OG002
Placebo
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Units
Counts
Participants
OG00050
OG00150
OG00251
Title
Denominators
Categories
AEs
Title
Measurements
OG00049
OG00149
OG00250
SAEs
Title
Measurements
OG0004
OG0010
OG0023
Discontinuations due to AEs
Title
Measurements
OG0004
OG0013
OG0022
Grade 2-4 Treatment-related AEs
Title
Measurements
OG00027
OG00122
OG00230
Deaths
Title
Measurements
OG0000
OG0010
OG0020
OG002
Placebo: Follow-up
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.