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Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341871
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.

Condition or disease
Hepatitis C Virus (HCV)

Study Design
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Study Type : Observational
Actual Enrollment : 1095 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Actual Study Start Date : December 27, 2017
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
HCV Genotypes 1, 2, 3, 4, 5, or 6 participants
Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last dose of drug ]
    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.


Secondary Outcome Measures :
  1. Percentage of Participants with Post-treatment Relapse [ Time Frame: Up to 24 weeks after last dose of 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.

  2. Percentage of Participants with On-treatment Virologic Failure [ Time Frame: Up to 12 weeks after first dose ]
    On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.

  3. Percentage of Participants Achieving SVR4 [ Time Frame: 4 weeks after last dose ]
    SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.

  4. Percentage of Participants Achieving SVR8 [ Time Frame: 8 weeks after last dose of drug ]
    SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.

  5. Percentage of Participants Achieving SVR24 [ Time Frame: 24 weeks after last dose of drug ]
    SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.


Eligibility Criteria
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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.
Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.

Exclusion Criteria:

  • Patients previously treated with glecaprevir plus pibrentasvir.
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): NCT03341871


Locations
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Japan
Abbvie Japan /ID# 161985
Tokyo, Japan, 108-6302
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03341871    
Other Study ID Numbers: P16-570
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
chronic hepatitis C virus (HCV)
Genotype
glecaprevir
pibrentasvir
sustained virologic response
chronic hepatitis C virus genotype 1
 chronic hepatitis C virus genotype 2
chronic hepatitis C virus genotype 3
chronic hepatitis C virus genotype 4
chronic hepatitis C virus genotype 5
chronic hepatitis C virus genotype 6
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections