Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)

AbbVie0 sites173 target enrollmentOctober 6, 2015

ConditionsChronic Hepatitis C

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 173
Primary Endpoint: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.

Registry

clinicaltrials.gov

Start Date

October 6, 2015

End Date

January 12, 2017

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
•If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
•Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
•Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Time Frame: 12 Weeks after the last dose of study drug

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels \< 50 IU/mL 12 weeks after the last actual dose of study drug.

Secondary Outcomes

Percentage of Participants With Virological Response at End of Treatment (EoTR)(Up to 24 weeks of treatment)
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)(12 weeks after last dose of study drug)
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)(Up to approximately 24 weeks)
Percentage of Participants With Post-treatment Relapse(Up to 12 weeks after last dose of study drug)