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A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

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ClinicalTrials.gov Identifier: NCT03089944
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE March 22, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE April 28, 2017
Estimated Primary Completion Date August 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected participants in the Per Protocol (PP) Population [ 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 study drug.
  • Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected participants in the Intent-To-Treat (ITT) Population [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 was defined as HCV RNA level less than the LLOQ 12 weeks after the last dose of study drug in the ITT Population.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the per protocol population [ 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 study drug.
Change History Complete list of historical versions of study NCT03089944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • Percentage of Participants With SVR12 in HCV GT3-infected and HCV GT1-6-infected participants in the PP Population [ Time Frame: Up to 12 weeks while on treatment ]
    SVR12 was defined as HCV RNA level less than the LLOQ 12 weeks after the last dose of study drug
  • Percentage of Participants With SVR12 in HCV GT3-infected and HCV GT1-6-infected participants in the ITT Population [ Time Frame: Up to 12 weeks after the last dose of study drug ]
    SVR12 was defined as HCV RNA level less than the LLOQ 12 weeks after the last dose of study drug
  • Percentage of Participants (for HCV GT1,2,4,5 and 6-infected, HCV GT3-infected and HCV GT1-6-infected) with On-treatment Virologic Failure [ Time Frame: Up to 12 weeks while on 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 (for HCV GT1,2,4,5 and 6-infected, HCV GT3-infected and HCV GT1-6-infected) With Post-treatment Relapse [ Time Frame: Up to 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 with HCV RNA levels < LLOQ at the end of treatment, excluding participants who have been shown to be re-infected.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • Percentage of Participants With SVR12 in the intent-to-treat population [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 was defined as HCV RNA level less than the LLOQ 12 weeks after the last dose of study drug in the intent-to-treat population.
  • Percentage of Participants with On-treatment Virologic Failure [ Time Frame: Up to 12 weeks while on 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: Up to 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 with HCV RNA levels < LLOQ at the end of treatment, excluding participants who have been shown to be re-infected.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Official Title  ICMJE A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Brief Summary A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus (HCV)
Intervention  ICMJE Drug: Glecaprevir/Pibrentasvir
Tablet
Other Names:
  • ABT-493
  • ABT-530
Study Arms  ICMJE Experimental: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
Intervention: Drug: Glecaprevir/Pibrentasvir
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
342
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
270
Estimated Study Completion Date  ICMJE November 10, 2019
Estimated Primary Completion Date August 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
  • Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
  • Treatment-naive to any approved or investigational anti-HCV medication.
  • Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

Exclusion Criteria:

  • Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
  • Any current or historical clinical evidence of decompensated cirrhosis.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
  • History of suspected or confirmed hepatocellular carcinoma.
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 Bulgaria,   Canada,   Czechia,   France,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States,   Vietnam
Removed Location Countries American Samoa,   Mexico
 
Administrative Information
NCT Number  ICMJE NCT03089944
Other Study ID Numbers  ICMJE M16-135
2016-004967-38 ( 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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2019

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