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

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ClinicalTrials.gov Identifier: NCT02640157
Recruitment Status : Completed
First Posted : December 28, 2015
Results First Posted : September 15, 2017
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 22, 2015
First Posted Date  ICMJE December 28, 2015
Results First Submitted Date  ICMJE August 17, 2017
Results First Posted Date  ICMJE September 15, 2017
Last Update Posted Date July 30, 2021
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B [ Time Frame: 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%.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A [ Time Frame: 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%.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
Percentage of Participants With Sustained Virologic Response 12 weeks After Treatment (SVR12): Non-inferiority Analysis [ Time Frame: 12 weeks after last dose of study drug ]
SVR 12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B [ Time Frame: 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.
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: 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.
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Percentage of Participants With Sustained Virologic Response 12 weeks After Treatment (SVR12): Superiority Analysis [ Time Frame: 12 weeks after last dose of study drug ]
    SVR 12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: 12 weeks ]
    Confirmed quantifiable hepatitis C virus ribonucleic acid among participants with previously unquantifiable hepatitis C virus ribonucleic acid during treatment
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: Within 12 weeks post treatment ]
    HCV RNA greater than the LLOQ between the end of treatment and 12 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • Hepatitis C Virus
  • Genotype 3 Hepatitis C Virus
Intervention  ICMJE
  • 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
  • Drug: Sofosbuvir
    Tablet
    Other Name: Sovaldi
  • Drug: Daclatasvir
    Tablet
    Other Name: Daklinza
Study Arms  ICMJE
  • Experimental: Arm A
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
    Intervention: Drug: ABT-493/ABT-530
  • Active Comparator: Arm B
    Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: Daclatasvir
  • Experimental: Arm C
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Intervention: Drug: ABT-493/ABT-530
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
506
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2015)
345
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Canada,   France,   Germany,   New Zealand,   Russian Federation,   Sweden,   Switzerland,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT02640157
Other Study ID Numbers  ICMJE M13-594
2015-002272-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc AbbVie
PRS Account AbbVie
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP