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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 : Recruiting
First Posted : March 24, 2017
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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 Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : August 24, 2019
Estimated Study Completion Date : November 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
Drug: Glecaprevir/Pibrentasvir
Tablet
Other Names:
  • ABT-493
  • ABT-530




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.



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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:

  • 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.

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): NCT03089944


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Show 113 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03089944     History of Changes
Other Study ID Numbers: M16-135
2016-004967-38 ( EudraCT Number )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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

Keywords provided by AbbVie:
Hepatitis C Virus (HCV)
Glecaprevir
Pibrentasvir
Treatment Naïve
Cirrhosis
Compensated Cirrhosis
Genotype (GT) 1-6
Pangenotypic
Chronic Hepatitis C Virus (HCV)

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