Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

Overview

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.

Full Title of Study: “Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 26, 2019

Arms, Groups and Cohorts

  • Chronic infection of hepatitis C virus (HCV) genotype 2
    • Participants with confirmed chronic HCV genotype 2, receiving paritaprevir/ritonavir/ombitasvir and ribavirin according to standard of care and in line with the current local label

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants with Sustained Virologic Response (SVR12)
    • Time Frame: 12 weeks after last dose of study drug.
    • Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

Secondary Measures

  • Percentage of Participants with Virologic Failure During Treatment (breakthrough)
    • Time Frame: Up to 12 Weeks
    • HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.
  • Percentage of Participants with Virologic Failure After Treatment (relapse)
    • Time Frame: Post-treatment 24 weeks
    • Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.
  • Percentage of Participants with Sustained Virologic Response (SVR24)
    • Time Frame: 24 weeks after the last dose of study drug
    • HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

Participating in This Clinical Trial

Inclusion Criteria

  • HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice. Exclusion Criteria:

  • Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AbbVie Inc., Study Director, AbbVie

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