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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)

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ClinicalTrials.gov Identifier: NCT02651194
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus (HCV) Infection Drug: ABT-493/ABT-530 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)
Actual Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ABT-493/ABT-530
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ 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


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: up to 12 weeks ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C virus (HCV) infection
  • Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
  • Subject must be HCV treatment-naïve or have failed previous HCV treatment.
  • Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
  • Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
  • Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is 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 preclude 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 antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
  • Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651194


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02651194    
Other Study ID Numbers: M15-462
2015-002353-35 ( EudraCT Number )
First Posted: January 8, 2016    Key Record Dates
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: September 2017
Keywords provided by AbbVie:
Treatment-naïve
HCV Gentoype 2
Non-cirrhotic
Chronic Hepatitis C
HCV Gentoype 5
HCV Gentoype 4
 HCV Gentoype 6
HCV Gentoype 1
Compensated cirrhotic
Treatment-experienced
HCV Gentoype 3
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections