Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02629172

Enrollment

3043

Registered

2015-12-14

Start date

2016-01-05

Completion date

2019-02-28

Last updated

2020-02-24

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

Hepatitis C Virus (HCV), Paritaprevir, Ombitasvir, Ritonavir, Genotype 1

Brief summary

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 120 Years

Healthy volunteers

Inclusion criteria

* HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice

Exclusion criteria

* Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants with Sustained Virologic Response (SVR12)	12 weeks after the last dose of study drug	Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.

Secondary

Measure	Time frame	Description
Percentage of Participants with Virologic Failure After Treatment	Post-treatment 24 weeks	Confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) at the end of 12 week treatment but subsequent viremia with HCV RNA greater than or equal to the lower limit of quantitation during 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	Hepatitis C virus ribonucleic acid less than the lower limit of quantification 24 weeks after the last dose of study drug.
Percentage of Participants with Virologic Failure During Treatment	Up to Week 12	HCV RNA levels reach less than the lower limit of quantitation (LLOQ), then increase to greater than or equal to the LLOQ at any point during treatment.

Countries

Japan

Outcome results