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

September 14, 2021 updated by: AbbVie
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1095

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 108-6302
        • Abbvie Japan /ID# 161985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients previously treated with glecaprevir plus pibrentasvir.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after last dose of drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks after last dose of drug
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.
Up to 12 weeks after first dose
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 weeks after last dose
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.
8 weeks after last dose of drug
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.
24 weeks after last dose of drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

September 15, 2020

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16-570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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