Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor AbbVie
Collaborator IST GmbH, Germany
Start date November 2015
End date March 2017
Trial size 100 participants
Trial identifier NCT02640547, P15-767, PLHCVRWE01

Summary

This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of Paritaprevir (PTV)/ritonavir (r) + Ombitasvir (OBV), +/- Dasabuvir (DSV), +/- Ribavirin in chronic hepatitis C virus infected participants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
GT1 participants receiving PTV/r+OBV+DSV for 12 weeks
GT1 participants receiving PTV/r+OBV+DSV+RBV for 12 weeks
GT1 participants receiving PTV/r+OBV+DSV+RBV for 24 weeks
GT4 participants receiving PTV/r+OBV+RBV for 12 weeks
GT4 participants receiving PTV/r+OBV+RBV for 24 weeks.

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
Evaluate the Usage Pattern of the Treatment Regimen
time frame: Up to end of treatment, maximum week 24
Percentage of the Direct Acting Antiviral (DAA) Dose taken in Relation to the Target Dose of DAA
time frame: Up to end of treatment, maximum week 24
Percentage of the Ribavirin (RBV) dose taken in relation to the target dose of RBV
time frame: Up to end of treatment, maximum week 24
Percentage of Missed RBV Treatment Days in Relation to the Target Number of RBV Treatment Days
time frame: Up to end of treatment, maximum week 24
Number of Participants with Co-morbidities
time frame: Day 0
Number of Participants with Concomitant Medications
time frame: Day 0 to end of treatment, maximum week 24
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 24
Change in Participants Workability Measured with the Work Productivity and Activity Impairment (WPAI):Hepatitis C Questionnaire
time frame: Day 0 to post treatment week 24

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 CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± 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/or 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 (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)
Principal investigator Robert Flisiak, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.