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Completed

NCT Number: NCT03341871

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

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.

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbvie Japan /ID# 161985

Tokyo, 108-6302, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients previously treated with glecaprevir plus pibrentasvir.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2017
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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