A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01715415
Collaborator
(none)
395
Enrollment
2
Arms
23
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: ABT-450/r/ABT-267, ABT-333
  • Drug: Ribavirin
  • Drug: Placebo for ABT-450/r/ABT-267
  • Drug: Placebo for ABT-333
  • Drug: Placebo for ribavirin
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
395 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

ArmIntervention/Treatment
Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV

Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Drug: ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
  • Drug: Ribavirin
    Capsule (double-blind treatment period), tablet (open-label treatment period)

    Experimental: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV

    Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
  • Drug: Ribavirin
    Capsule (double-blind treatment period), tablet (open-label treatment period)

    Drug: Placebo for ABT-450/r/ABT-267
    Tablet

    Drug: Placebo for ABT-333
    Tablet

    Drug: Placebo for ribavirin
    Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment [12 weeks after the last actual dose of active study drug]

      The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

    Secondary Outcome Measures

    1. Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period [At 12 weeks]

      Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.

    2. Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [12 weeks after the last actual dose of active study drug]

      The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

    3. Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment [12 weeks after the last actual dose of active study drug]

      The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

    4. Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [12 weeks after the last actual dose of active study drug]

      Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.

    5. Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm [Within 12 weeks post-treatment]

      Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.

    • Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.

    • Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).

    • No evidence of liver cirrhosis.

    Exclusion Criteria:
    • Positive screen for drugs or alcohol.

    • Significant sensitivity to any drug.

    • Use of contraindicated medications within 2 weeks of dosing.

    • Certain predefined abnormal laboratory tests.

    • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Jeff Enejosa, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01715415
    Other Study ID Numbers:
    • M13-098
    • 2012-002035-29
    First Posted:
    Oct 29, 2012
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVPlacebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeksDouble-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Period Title: Double-blind Treatment
    STARTED29798
    Randomized But Not Treated01
    COMPLETED29296
    NOT COMPLETED52
    Period Title: Double-blind Treatment
    STARTED096
    COMPLETED094
    NOT COMPLETED02

    Baseline Characteristics

    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVPlaceboTotal
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeksDouble-blind placebo for 12 weeksTotal of all reporting groups
    Overall Participants29797394
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.7
    (10.26)
    54.9
    (8.46)
    52.5
    (9.93)
    Sex: Female, Male (Count of Participants)
    Female
    130
    43.8%
    37
    38.1%
    167
    42.4%
    Male
    167
    56.2%
    60
    61.9%
    227
    57.6%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
    DescriptionThe percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame12 weeks after the last actual dose of active study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Measure Participants297
    Number [percentage of participants]
    96.3
    32.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Comments With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants with SVR12
    Estimated Value96.3
    Confidence Interval (2-Sided) 95%
    94.1 to 98.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.
    2. Secondary Outcome
    TitlePercentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
    DescriptionNormalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
    Time FrameAt 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVPlacebo
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeksDouble-blind placebo for 12 weeks
    Measure Participants22478
    Number [percentage of participants]
    96.9
    32.6%
    12.8
    13.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV, Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    CommentsIn order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.
    MethodFisher Exact
    Comments
    3. Secondary Outcome
    TitlePercentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    DescriptionThe percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame12 weeks after the last actual dose of active study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Measure Participants173
    Number [percentage of participants]
    96.0
    32.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants with SVR12
    Estimated Value96.0
    Confidence Interval (2-Sided) 95%
    93.0 to 98.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI calculated using the normal approximation to the binomial distribution.
    4. Secondary Outcome
    TitlePercentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
    DescriptionThe percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame12 weeks after the last actual dose of active study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Measure Participants123
    Number [percentage of participants]
    96.7
    32.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants with SVR12
    Estimated Value96.7
    Confidence Interval (2-Sided) 95%
    93.6 to 99.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    TitlePercentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    DescriptionVirologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
    Time Frame12 weeks after the last actual dose of active study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Measure Participants297
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    6. Secondary Outcome
    TitlePercentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
    DescriptionParticipants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
    Time FrameWithin 12 weeks post-treatment

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    Measure Participants293
    Number (95% Confidence Interval) [percentage of participants]
    2.4
    0.8%

    Adverse Events

    Time FrameAdverse events (AEs) were collected from the start of active study drug administration (double-blind [DB] or open-label [OL] active) to 30 days after the last dose of active study drug (total 16 weeks).
    Adverse Event Reporting Description DB Placebo Arm: AEs collected from start of placebo until 30 days following discontinuation of placebo and prior to the OL period (if applicable; total 16 weeks). Serious AES collected from informed consent until the end of participation in the study (12 weeks, DB period; 12 weeks, OL period + 48-week post-treatment period; total up to 72 weeks).
    Arm/Group TitleDouble Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm/Group DescriptionDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeksDouble-blind placebo for 12 weeksOpen-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
    All Cause Mortality
    Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total6/297 (2%) 1/97 (1%) 3/96 (3.1%)
    Cardiac disorders
    ATRIAL FIBRILLATION0/297 (0%) 1/97 (1%) 0/96 (0%)
    BRADYCARDIA1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Gastrointestinal disorders
    INTESTINAL OBSTRUCTION1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    NAUSEA1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    VOMITING1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Hepatobiliary disorders
    BILE DUCT STONE0/297 (0%) 0/97 (0%) 1/96 (1%)
    Infections and infestations
    PNEUMONIA1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Nervous system disorders
    CEREBROVASCULAR ACCIDENT1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    DIZZINESS1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Renal and urinary disorders
    CALCULUS URETERIC0/297 (0%) 0/97 (0%) 1/96 (1%)
    RENAL FAILURE ACUTE1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE1/297 (0.3%) 0/97 (0%) 0/96 (0%)
    Skin and subcutaneous tissue disorders
    ANGIOEDEMA0/297 (0%) 0/97 (0%) 1/96 (1%)
    Other (Not Including Serious) Adverse Events
    Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total254/297 (85.5%) 74/97 (76.3%) 74/96 (77.1%)
    Blood and lymphatic system disorders
    ANAEMIA16/297 (5.4%) 0/97 (0%) 3/96 (3.1%)
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER16/297 (5.4%) 6/97 (6.2%) 9/96 (9.4%)
    CONSTIPATION4/297 (1.3%) 6/97 (6.2%) 0/96 (0%)
    DIARRHOEA39/297 (13.1%) 12/97 (12.4%) 8/96 (8.3%)
    DYSPEPSIA18/297 (6.1%) 3/97 (3.1%) 7/96 (7.3%)
    NAUSEA59/297 (19.9%) 17/97 (17.5%) 13/96 (13.5%)
    VOMITING19/297 (6.4%) 0/97 (0%) 3/96 (3.1%)
    General disorders
    ASTHENIA47/297 (15.8%) 11/97 (11.3%) 13/96 (13.5%)
    FATIGUE99/297 (33.3%) 22/97 (22.7%) 16/96 (16.7%)
    IRRITABILITY16/297 (5.4%) 8/97 (8.2%) 6/96 (6.3%)
    Infections and infestations
    NASOPHARYNGITIS21/297 (7.1%) 5/97 (5.2%) 8/96 (8.3%)
    Metabolism and nutrition disorders
    DECREASED APPETITE20/297 (6.7%) 2/97 (2.1%) 4/96 (4.2%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA19/297 (6.4%) 7/97 (7.2%) 2/96 (2.1%)
    BACK PAIN15/297 (5.1%) 3/97 (3.1%) 3/96 (3.1%)
    MYALGIA23/297 (7.7%) 10/97 (10.3%) 5/96 (5.2%)
    Nervous system disorders
    DIZZINESS25/297 (8.4%) 5/97 (5.2%) 5/96 (5.2%)
    DYSGEUSIA10/297 (3.4%) 5/97 (5.2%) 3/96 (3.1%)
    HEADACHE108/297 (36.4%) 34/97 (35.1%) 18/96 (18.8%)
    Psychiatric disorders
    ANXIETY14/297 (4.7%) 4/97 (4.1%) 7/96 (7.3%)
    DEPRESSED MOOD5/297 (1.7%) 5/97 (5.2%) 1/96 (1%)
    INSOMNIA42/297 (14.1%) 7/97 (7.2%) 10/96 (10.4%)
    Respiratory, thoracic and mediastinal disorders
    COUGH32/297 (10.8%) 5/97 (5.2%) 11/96 (11.5%)
    DYSPNOEA37/297 (12.5%) 10/97 (10.3%) 13/96 (13.5%)
    DYSPNOEA EXERTIONAL12/297 (4%) 5/97 (5.2%) 8/96 (8.3%)
    Skin and subcutaneous tissue disorders
    DRY SKIN22/297 (7.4%) 3/97 (3.1%) 5/96 (5.2%)
    PRURITUS41/297 (13.8%) 5/97 (5.2%) 12/96 (12.5%)
    PRURITUS GENERALISED11/297 (3.7%) 5/97 (5.2%) 3/96 (3.1%)
    RASH26/297 (8.8%) 6/97 (6.2%) 8/96 (8.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/TitleGlobal Medical Information
    OrganizationAbbVie (prior sponsor, Abbott)
    Phone800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01715415
    Other Study ID Numbers:
    • M13-098
    • 2012-002035-29
    First Posted:
    Oct 29, 2012
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021