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NCT03341871 Clinical Trial

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

Hepatitis C Virus (HCV) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03341871
Other study ID # P16-570
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2017
Est. completion date September 15, 2020

Study information
Verified date September 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1095
Est. completion date September 15, 2020
Est. primary completion date September 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria: - Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir. Exclusion Criteria: - Patients previously treated with glecaprevir plus pibrentasvir.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Abbvie Japan /ID# 161985 Tokyo

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants with Post-treatment Relapse 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
Secondary Percentage of Participants with On-treatment Virologic Failure 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
Secondary Percentage of Participants Achieving SVR4 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
Secondary Percentage of Participants Achieving SVR8 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
Secondary Percentage of Participants Achieving SVR24 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
See also
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