Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
1 other identifier
observational
1,095
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
December 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedSeptember 20, 2021
September 1, 2021
2.7 years
November 9, 2017
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
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 Outcomes (5)
Percentage of Participants with Post-treatment Relapse
Up to 24 weeks after last dose of drug
Percentage of Participants with On-treatment Virologic Failure
Up to 12 weeks after first dose
Percentage of Participants Achieving SVR4
4 weeks after last dose
Percentage of Participants Achieving SVR8
8 weeks after last dose of drug
Percentage of Participants Achieving SVR24
24 weeks after last dose of drug
Study Arms (1)
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.
Eligibility Criteria
Japan patients infected with hepatitis C virus and treating with glecaprevir plus pibrentasvir per approved Japan label.
You may qualify if:
- Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
You may not qualify if:
- Patients previously treated with glecaprevir plus pibrentasvir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (1)
Abbvie Japan /ID# 161985
Tokyo, 108-6302, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 14, 2017
Study Start
December 27, 2017
Primary Completion
September 15, 2020
Study Completion
September 15, 2020
Last Updated
September 20, 2021
Record last verified: 2021-09