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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03341871

Enrollment

1095

Registered

2017-11-14

Start date

2017-12-27

Completion date

2020-09-15

Last updated

2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus (HCV)

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 99 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients previously treated with glecaprevir plus pibrentasvir.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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 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.

Countries

Japan

Outcome results