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

Completed

• Conditions: Hepatitis C Virus (HCV)

• Registration Number: NCT03341871
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2017-12-27
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

Inclusion Criteria

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

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Exclusion Criteria

• Patients previously treated with glecaprevir plus pibrentasvir.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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

Name	Time	Method
Percentage of Participants with Post-treatment Relapse	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.
Percentage of Participants with On-treatment Virologic Failure	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.
Percentage of Participants Achieving SVR24	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.
Percentage of Participants Achieving SVR8	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.
Percentage of Participants Achieving SVR4	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.

Trial Locations

Locations (1)

Abbvie Japan /ID# 161985; 🇯🇵 Tokyo, Japan