A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/... | NCT01458535 | Trialant
NCT01458535
Sponsor
AbbVie (prior sponsor, Abbott)
Status
Completed
Last Update Posted
Jul 11, 2016Estimated
Enrollment
61Actual
Phase
Phase 2
Conditions
Hepatitis C Virus
Interventions
ABT-450
ABT-267
ribavirin
ritonavir
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01458535
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M12-998
Secondary IDs
Not provided
Brief Title
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Official Title
An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
Acronym
Navigator
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2016
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
Sep 2011
Primary Completion Date
May 2013Actual
Completion Date
May 2013Actual
First Submitted Date
Sep 23, 2011
First Submission Date that Met QC Criteria
Oct 21, 2011
First Posted Date
Oct 25, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 31, 2016
Results First Submitted that Met QC Criteria
May 31, 2016
Results First Posted Date
Jul 11, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 30, 2014
Certification/Extension First Submitted that Passed QC Review
May 30, 2014
Certification/Extension First Posted Date
Jun 17, 2014Estimated
Last Update Submitted Date
May 31, 2016
Last Update Posted Date
Jul 11, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVie (prior sponsor, Abbott)INDUSTRY
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
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
Detailed Description
This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.
Conditions Module
Conditions
Hepatitis C Virus
Keywords
Genotype 1
Genotype 2
Genotype 3
Hepatitis C Virus
ABT-450/r
Ribavirin
ABT-267
Ombitasvir
Paritaprevir
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ribavirin
Drug: ritonavir
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ribavirin
Drug: ritonavir
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ribavirin
Drug: ritonavir
ABT-450/r and ABT-267 in genotype 1 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ritonavir
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABT-450
Drug
tablets
ABT-450/r and ABT-267 in genotype 1 participants
ABT-450/r and ABT-267 in genotype 2 participants
ABT-450/r and ABT-267 in genotype 3 participants
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
Week 4 through Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Post-treatment Day 1 to Post-treatment Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who had a body mass index 18 to < 35 kg/m^2.
Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
Participants were in a condition of general good health, other than the HCV infection.
Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
Exclusion Criteria:
Positive drug screen
Previous use of anti-HCV agents
History of cardiac disease
History of uncontrolled diabetes or diabetes requiring insulin
Abnormal laboratory results
Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
FG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
Puerto Rico
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
ABT-450/r and ABT-267 in genotype 2 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ritonavir
ABT-450/r and ABT-267 in genotype 3 participants
Experimental
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
Drug: ABT-450
Drug: ABT-267
Drug: ritonavir
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
paritaprevir
ABT-267
Drug
tablets
ABT-450/r and ABT-267 in genotype 1 participants
ABT-450/r and ABT-267 in genotype 2 participants
ABT-450/r and ABT-267 in genotype 3 participants
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
ombitasvir
ribavirin
Drug
tablets
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
ritonavir
Drug
capsules
ABT-450/r and ABT-267 in genotype 1 participants
ABT-450/r and ABT-267 in genotype 2 participants
ABT-450/r and ABT-267 in genotype 3 participants
ABT-450/r and ABT-267 plus RBV in genotype 1 participants
ABT-450/r and ABT-267 plus RBV in genotype 2 participants
ABT-450/r and ABT-267 plus RBV in genotype 3 participants
Norvir
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Post-treatment Day 1 to Post-treatment Week 24
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
Week 4
Percentage of Participants With Virologic Failure During Treatment
Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).
Day 1 through Week 12
Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.
Post-treatment Day 1 to Post-treatment Week 48
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
FG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
FG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
FG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
FG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG00511 subjects
COMPLETED
FG00010 subjects
FG0018 subjects
FG0028 subjects
FG0036 subjects
FG0046 subjects
FG0057 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
BG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
BG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
BG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
BG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
BG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG00310
BG00410
BG00511
BG00661
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
BG00044.3± 12.19
BG00151.1± 8.25
BG00240.3± 13.10
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0012
BG002
HCV Genotype/ Subtype
Number
participants
Title
Denominators
Categories
1A
Title
Measurements
BG0008
BG0010
BG002
Interleukin 28B (IL28B)
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0001
BG0012
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 With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Week 4 through Week 12
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100
OG00190.0
OG00270.0
OG003
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
OG003
Cochran-Mantel-Haenszel
0.157
No
Superiority or Other
OG001
OG004
Cochran-Mantel-Haenszel
0.999
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Post-treatment Day 1 to Post-treatment Week 12
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Post-treatment Day 1 to Post-treatment Week 24
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Week 2
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
OG003
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
Secondary
Percentage of Participants With Virologic Failure During Treatment
Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Posted
Number
percentage of participants
Day 1 through Week 12
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
Secondary
Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.
Posted
Number
percentage of participants
Post-treatment Day 1 to Post-treatment Week 48
ID
Title
Description
OG000
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
OG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
OG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
Time Frame
AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 60 weeks).
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
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
1
10
9
10
EG001
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
0
10
9
10
EG002
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
0
10
8
10
EG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
1
10
9
10
EG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
1
10
9
10
EG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
1
11
10
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HAEMATEMESIS
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected11 at risk
CLOSTRIDIAL INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MENINGITIS HERPES
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
FACIAL BONES FRACTURE
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
LUMBAR VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
TRAUMATIC LIVER INJURY
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HEPATIC NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ARTERIOSCLEROSIS
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected11 at risk
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HYPERACUSIS
Ear and labyrinth disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
GROWTH OF EYELASHES
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ERUCTATION
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
FAECES PALE
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
IMPAIRED GASTRIC EMPTYING
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0006 affected10 at risk
EG0013 affected10 at risk
EG0021 affected10 at risk
EG003
SENSITIVITY OF TEETH
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
FATIGUE
General disorders
MedDRA 15.0
Systematic Assessment
EG0006 affected10 at risk
EG0013 affected10 at risk
EG0022 affected10 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
IRRITABILITY
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
MALAISE
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
PAIN
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
PYREXIA
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
JAUNDICE
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
GROIN INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
KIDNEY INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0003 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
TONGUE ABSCESS
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
INJURY
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
POST-TRAUMATIC PAIN
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
BLOOD TRIGLYCERIDES INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
CREATININE RENAL CLEARANCE DECREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG003
INTRAOCULAR PRESSURE INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
URINE OUTPUT INCREASED
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
OSTEOPENIA
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
LIPOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
SKIN CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
TRANSITIONAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0004 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
BREAST TENDERNESS
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
CYSTOCELE
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PROSTATITIS
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
COLD SWEAT
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
INCREASED TENDENCY TO BRUISE
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 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
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
AbbVie
800-633-9110
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
C585405
paritaprevir
C586094
ombitasvir
D012254
Ribavirin
D019438
Ritonavir
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
2 subjects
FG0052 subjects
0 subjects
FG0050 subjects
45.9
± 7.03
BG00454.9± 10.85
BG00548.7± 8.91
BG00647.6± 10.90
3
BG0037
BG0043
BG0054
BG00627
Male
BG0002
BG0018
BG0027
BG0033
BG0047
BG0057
BG00634
0
BG0038
BG0040
BG0050
BG00616
1B
Title
Measurements
BG0002
BG0010
BG0020
BG0032
BG0040
BG0050
BG0064
2A
Title
Measurements
BG0000
BG0012
BG0020
BG0030
BG0042
BG0050
BG0064
2B
Title
Measurements
BG0000
BG0018
BG0020
BG0030
BG0048
BG0050
BG00616
3A
Title
Measurements
BG0000
BG0010
BG00210
BG0030
BG0040
BG00511
BG00621
3B
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
2
BG0034
BG0044
BG0053
BG00616
CT
Title
Measurements
BG0007
BG0014
BG0027
BG0034
BG0045
BG0057
BG00634
TT
Title
Measurements
BG0002
BG0014
BG0021
BG0032
BG0041
BG0051
BG00611
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
10
OG00410
OG00511
90.0
OG00480.0
OG00518.2
No
Superiority or Other
OG002
OG005
Cochran-Mantel-Haenszel
0.045
No
Superiority or Other
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00511
Title
Denominators
Categories
Title
Measurements
OG000100
OG00180.0
OG00250.0
OG00360.0
OG00460.0
OG0059.1
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00511
Title
Denominators
Categories
Title
Measurements
OG000100
OG00180.0
OG00240.0
OG00360.0
OG00460.0
OG0059.1
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00511
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00511
Title
Denominators
Categories
Title
Measurements
OG000100
OG001100
OG00290.0
OG003100
OG00490.0
OG00527.3
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00511
Title
Denominators
Categories
Participant Rebounds
Title
Measurements
OG0000
OG00110.0
OG00230.0
OG00310.0
OG00410.0
OG00572.7
Participants who fail to Suppress
Title
Measurements
OG0000
OG0010
OG0020
OG003
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
OG003
ABT-450/r and ABT-267 in Genotype 1 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
OG004
ABT-450/r and ABT-267 in Genotype 2 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
OG005
ABT-450/r and ABT-267 in Genotype 3 Participants
ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.