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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02945228

Enrollment

449

Registered

2016-10-26

Start date

2016-10-26

Completion date

2019-07-26

Last updated

2020-06-12

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

Conditions

Chronic Hepatitis C Virus

Keywords

Genotype 2, Paritaprevir, Hepatitis C Virus (HCV), Ritonavir, Ombitasvir

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants with Sustained Virologic Response (SVR12)	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

Measure	Time frame	Description
Percentage of Participants with Virologic Failure During Treatment (breakthrough)	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)	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)	24 weeks after the last dose of study drug	HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

Countries

Japan

Outcome results