Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor AbbVie
Start date October 2015
End date July 2017
Trial size 170 participants
Trial identifier NCT02582658, P15-695

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 +/- Ribavirin (RBV) in chronic hepatitis C virus infected participants in Austria.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants with confirmed chronic hepatitis C genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label

Primary Outcomes

Measure
Percentage of participants achieving sustained virological response 12 Weeks Post-treatment (SVR12)
time frame: 12 Weeks after the last dose of study drug

Secondary Outcomes

Measure
Usage pattern of treatment regimen in Austria
time frame: Up to post treatment 12 week
Percentage of the direct-acting antiviral (DAA) dose taken in relation to the target dose of DAA
time frame: Up to post treatment week 12
Percentage of the Ribavirin (RBV) dose taken in relation to the target dose of RBV
time frame: Up to post treatment week 12
Percentage of missed Ribavirin (RBV) treatment days in relation to the target number of RBV treatment days
time frame: Up to post treatment week 12
Number of participants with concomitant medications
time frame: Day 0 to end of treatment
Number of participants with co-morbidities
time frame: Day 0
Change in participants workability measured with the Work Productivity and Activity Impairment (WPAI):Hepatitis C questionnaire
time frame: Day 0 to post treatment week 12
Change in participants quality of life measured with the EuroQol 5 dimension 5 level (EQ-5D-5L) questionnaire
time frame: Day 0 to post treatment week 12
Change of participant activation with the Patient activation Measure (PAM-13) questionnaire.
time frame: Day 0 to post treatment week 12
Patient support program (PSP) utilization and satisfaction assessment
time frame: Up to post treatment week 12

Eligibility Criteria

All participants from 18 years up to 99 years old.

Inclusion Criteria: Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1 or 4, 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:

Additional Information

Official title Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by AbbVie.