ENDURANCE-3: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02640157
Collaborator
(none)
506
Enrollment
3
Arms
14.1
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

Detailed Description

This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Study Design

Study Type:
Interventional
Actual Enrollment :
506 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
  • Active Comparator: Arm B

    Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

    Drug: Sofosbuvir
    Tablet
    Other Names:
  • Sovaldi
  • Drug: Daclatasvir
    Tablet
    Other Names:
  • Daklinza
  • Experimental: Arm C

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

    Drug: ABT-493/ABT-530
    Tablet; ABT-493 coformulated with ABT-530
    Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B [12 weeks after the last actual dose of study drug]

      SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.

    2. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A [12 weeks after the last actual dose of study drug]

      SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B [12 weeks after the last actual dose of study drug]

      SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.

    2. Percentage of Participants With On-treatment Virologic Failure [Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment]

      On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

    3. Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of study drug]

      Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.

    • Screening laboratory result indicating HCV GT3 infection.

    • Chronic HCV infection, defined as one of the following:

    • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or

    • A liver biopsy consistent with chronic HCV infection; or

    • Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.

    • Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).

    • Documented as noncirrhotic.

    Exclusion Criteria:
    • Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.

    • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could have precluded adherence to the protocol in the opinion of the investigator.

    • Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus Ab (HIV Ab).

    • Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.

    • Any cause of liver disease other than chronic HCV infection.

    • Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.

    • History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.

    • Previous use of any anti-HCV treatment.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02640157
    Other Study ID Numbers:
    • M13-594
    • 2015-002272-24
    First Posted:
    Dec 28, 2015
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailA total of 506 participants were randomized and 505 received ≥ 1 dose of study drug. One participant in Arm B was randomized in error and never dispensed study drug. This participant is included in the total number of participants in Arm B who discontinued the study. This study included a 42-day screening period.
    Arm/Group TitleArm AArm BArm C
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Period Title: Overall Study
    STARTED233116157
    Received Study Drug233115157
    Completed Study Drug225112154
    Discontinued Study Drug833
    COMPLETED220111147
    NOT COMPLETED13510

    Baseline Characteristics

    Arm/Group TitleArm AArm BArm CTotal
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.Total of all reporting groups
    Overall Participants233115157505
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47.18
    (10.68)
    47.06
    (11.31)
    45.43
    (12.19)
    46.61
    (11.32)
    Sex: Female, Male (Count of Participants)
    Female
    112
    48.1%
    63
    54.8%
    64
    40.8%
    239
    47.3%
    Male
    121
    51.9%
    52
    45.2%
    93
    59.2%
    266
    52.7%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B
    DescriptionSVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.
    Time Frame12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as nonresponders.
    Arm/Group TitleArm AArm B
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
    Measure Participants233115
    Number (95% Confidence Interval) [percentage of participants]
    95.3
    40.9%
    96.5
    83.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
    Comments Difference in SVR12 rates (Arm A - Arm B).
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in percentage of participants
    Estimated Value-1.2
    Confidence Interval (2-Sided) 95%
    -5.6 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm A
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation Parameterpercentage of participants
    Estimated Value95.3
    Confidence Interval (2-Sided) 97.5%
    92.2 to 98.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
    Comments Difference in SVR12 rates (Arm A - Arm B).
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in percentage of participants
    Estimated Value-1.2
    Confidence Interval (2-Sided) 97.5%
    -6.2 to 3.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A
    DescriptionSVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.
    Time Frame12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.
    Arm/Group TitleArm AArm C
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Measure Participants233157
    Number (95% Confidence Interval) [percentage of participants]
    95.3
    40.9%
    94.9
    82.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
    Comments Difference in SVR12 rates (Arm C - Arm A)
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in percentage of participants
    Estimated Value-0.4
    Confidence Interval (2-Sided) 95%
    -4.8 to 4.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm B
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of participants
    Estimated Value94.9
    Confidence Interval (2-Sided) 97.5%
    91.0 to 98.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in percentage of participants
    Estimated Value-0.4
    Confidence Interval (2-Sided) 97.5%
    -5.4 to 4.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B
    DescriptionSVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.
    Time Frame12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.
    Arm/Group TitleArm AArm B
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
    Measure Participants233115
    Number (95% Confidence Interval) [percentage of participants]
    95.3
    40.9%
    96.5
    83.9%
    4. Secondary Outcome
    TitlePercentage of Participants With On-treatment Virologic Failure
    DescriptionOn-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
    Time FrameTreatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug (ITT population)
    Arm/Group TitleArm AArm BArm C
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Measure Participants233115157
    Number (95% Confidence Interval) [percentage of participants]
    0.4
    0.2%
    0
    0%
    0.6
    0.4%
    5. Secondary Outcome
    TitlePercentage of Participants With Post-treatment Relapse
    DescriptionPost-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
    Time FrameFrom the end of treatment through 12 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit
    Arm/Group TitleArm AArm BArm C
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Measure Participants222114150
    Number (95% Confidence Interval) [percentage of participants]
    1.4
    0.6%
    0.9
    0.8%
    3.3
    2.1%

    Adverse Events

    Time FrameTreatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).
    Adverse Event Reporting Description TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Arm/Group TitleArm AARM BARM C
    Arm/Group DescriptionABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    All Cause Mortality
    Arm AARM BARM C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Arm AARM BARM C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total5/233 (2.1%) 2/115 (1.7%) 3/157 (1.9%)
    Eye disorders
    ULCERATIVE KERATITIS0/233 (0%) 0/115 (0%) 1/157 (0.6%)
    Infections and infestations
    OPHTHALMIC HERPES SIMPLEX0/233 (0%) 0/115 (0%) 1/157 (0.6%)
    PNEUMONIA1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE0/233 (0%) 0/115 (0%) 1/157 (0.6%)
    LIMB INJURY1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    POISONING0/233 (0%) 0/115 (0%) 1/157 (0.6%)
    Metabolism and nutrition disorders
    IRON DEFICIENCY0/233 (0%) 1/115 (0.9%) 0/157 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PARANASAL SINUS AND NASAL CAVITY MALIGNANT NEOPLASM RECURRENT1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    Pregnancy, puerperium and perinatal conditions
    ABORTION MISSED1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    Psychiatric disorders
    DEPENDENCE0/233 (0%) 0/115 (0%) 1/157 (0.6%)
    SUBSTANCE-INDUCED PSYCHOTIC DISORDER0/233 (0%) 1/115 (0.9%) 0/157 (0%)
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    HYPOXIA1/233 (0.4%) 0/115 (0%) 0/157 (0%)
    Other (Not Including Serious) Adverse Events
    Arm AARM BARM C
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total126/233 (54.1%) 53/115 (46.1%) 64/157 (40.8%)
    Gastrointestinal disorders
    DIARRHOEA15/233 (6.4%) 4/115 (3.5%) 18/157 (11.5%)
    NAUSEA32/233 (13.7%) 15/115 (13%) 19/157 (12.1%)
    VOMITING10/233 (4.3%) 5/115 (4.3%) 9/157 (5.7%)
    General disorders
    ASTHENIA4/233 (1.7%) 7/115 (6.1%) 3/157 (1.9%)
    FATIGUE44/233 (18.9%) 16/115 (13.9%) 20/157 (12.7%)
    Infections and infestations
    NASOPHARYNGITIS12/233 (5.2%) 6/115 (5.2%) 4/157 (2.5%)
    UPPER RESPIRATORY TRACT INFECTION15/233 (6.4%) 4/115 (3.5%) 2/157 (1.3%)
    Nervous system disorders
    HEADACHE60/233 (25.8%) 21/115 (18.3%) 31/157 (19.7%)
    Psychiatric disorders
    INSOMNIA9/233 (3.9%) 6/115 (5.2%) 0/157 (0%)

    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 Services
    OrganizationAbbVie
    Phone800-633-9110
    Email
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02640157
    Other Study ID Numbers:
    • M13-594
    • 2015-002272-24
    First Posted:
    Dec 28, 2015
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021