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

Male or female 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 November 2016.
Information provided to ClinicalTrials.gov by AbbVie.