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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

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ClinicalTrials.gov Identifier: NCT02604017
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 703 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
Study Start Date : October 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABT-493/ABT-530 for 12 weeks
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

Experimental: ABT-493/ABT-530 for 8 weeks
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




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm [ 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 of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).

  2. Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later [ Time Frame: 12 weeks after last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

  3. Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants [ 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. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.


Secondary Outcome Measures :
  1. Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants [ Time Frame: 12 weeks after last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

  2. Percentage of Participants With SVR12 [ Time Frame: 12 weeks after last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

  3. Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants [ Time Frame: 12 weeks after last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

  4. Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants [ Time Frame: 12 weeks after last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.

  5. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) 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 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.

  6. Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants [ Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) 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 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.

  7. 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.

  8. Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants [ 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.



Information from the National Library of Medicine

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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:

  • Male or female, at least 18 years of age at time of screening.
  • Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
  • Chronic HCV infection.
  • Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
  • Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

  • HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

  • On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
  • 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).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
  • Chronic HIV type 2 (HIV-2) infection.

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): NCT02604017


Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02604017     History of Changes
Other Study ID Numbers: M13-590
2015-002087-17 ( EudraCT Number )
First Posted: November 13, 2015    Key Record Dates
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017
Last Verified: August 2017

Keywords provided by AbbVie:
HCV GT1
Non-cirrhotic
RBV Free
Without cirrhosis
Chronic Hepatitis C
Hepatitis C Genotype 1 (GT1)
IFN free
Hepatitis C
Ribavirin Free
Interferon (IFN) Free
HCV
Hepatitis C virus
DAA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections