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A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2) (EXPEDITION-2)

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ClinicalTrials.gov Identifier: NCT02738138
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE April 14, 2016
Results First Submitted Date  ICMJE February 27, 2018
Results First Posted Date  ICMJE May 9, 2018
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE May 17, 2016
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last 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 active study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Percentage of subjects with sustained virologic response 12 weeks after treatment [ Time Frame: 12 weeks after last dose of study drug ]
Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12 weeks ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
  • Percentage of subjects with on-treatment HCV (Hepatitis C Virus) virologic failure in subject [ Time Frame: Up to 12 weeks ]
    On treatment VF is defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment.
  • The percentage of subjects with post-treatment HCV relapse [ Time Frame: Up to 12 weeks after last dose of study drug ]
    Confirmed quantifiable Hepatitis C Virus ribonucleic acid between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment with unquantifiable Hepatitis C Virus ribonucleic acid 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 to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
Official Title  ICMJE A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)
Brief Summary The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C Virus Infection
  • Human Immunodeficiency Virus Infection
  • Chronic Hepatitis C
  • Compensated Cirrhosis and Non-cirrhotics
Intervention  ICMJE Drug: ABT-493 coformulated with ABT-530
Tablet
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET
Study Arms  ICMJE
  • Experimental: ABT-493/ABT-530 for 8 weeks
    HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
    Intervention: Drug: ABT-493 coformulated with ABT-530
  • Experimental: ABT-493/ABT-530 for 12 weeks
    HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
    Intervention: Drug: ABT-493 coformulated with 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: June 8, 2017)
153
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2016)
150
Actual Study Completion Date  ICMJE June 7, 2017
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, at least 18 years of age at time of Screening.
  2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
  3. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
  4. Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
  5. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have

    • CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
    • Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

  1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  2. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
  3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
  4. Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
  5. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (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,   Belarus,   France,   Germany,   Poland,   Puerto Rico,   Russian Federation,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT02738138
Other Study ID Numbers  ICMJE M14-730
2015-005577-20 ( 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 Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc AbbVie
PRS Account AbbVie
Verification Date April 2018

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