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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

November 11, 2015
November 13, 2015
August 17, 2017
September 14, 2017
September 14, 2017
October 2015
January 2017   (Final data collection date for primary outcome measure)
  • 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).
  • 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.
  • 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.
  • Percentage of participants achieving a 12-week sustained virologic response (SVR12) Post-treatment [ Time Frame: 12 weeks after last dose of study drug ]
    HCV RNA level less than the lower limit of quantification.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 8-week Arm compared to the 12-week Arm in the per protocol (PP) population. [ Time Frame: 12 weeks after last dose of study drug ]
    HCV RNA level less than the lower limit of quantification.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 8-week Arm compared to the 12-week Arm in the intent-to-treat (ITT) population. [ Time Frame: 12 weeks after last dose of study drug ]
    HCV RNA level less than the lower limit of quantification.
Complete list of historical versions of study NCT02604017 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 8 or 12 weeks while on treatment ]
    The percentage of participants with confirmed 1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment or; with confirmed, quantifiable HCV RNA among subjects with previous unquantifiable HCV RNA during treatment; or failure to suppress during treatment with at least 6 weeks of treatment.
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: Up to 12 weeks after the last dose of study drug ]
    Percentage of participants with confirmed quantifiable HCV RNA after completion of treatment among participants with unquantifiable HCV RNA at the end of treatment.
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
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)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Hepatitis C
  • Hepatitis C Virus
  • HCV
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 12 weeks
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
    Intervention: Drug: ABT-493/ABT-530
  • Experimental: ABT-493/ABT-530 for 8 weeks
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Intervention: Drug: ABT-493/ABT-530
Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourlière M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
703
600
January 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Austria,   Belgium,   Canada,   Chile,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
 
NCT02604017
M13-590
2015-002087-17 ( EudraCT Number )
No
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
August 2017

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