Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

Chronic Hepatitis C Clinical Trial

— REAL  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582658
• Other study ID #: P15-695
• Status: Completed
• Start date: October 6, 2015
• Est. completion date: January 12, 2017

Study information

• Verified date: October 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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:

none

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Planned Duration of Ribavirin (RBV) Taken	Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]).	Up to 24 weeks of treatment
Other	Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire	The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management.	Day 0 and End of Treatment (EoT)
Other	Percentage of Participants With Concomitant Medications	Percentage of participants taking at least 1 concomitant medication	Day 0 to end of treatment (up to 24 weeks)
Other	Percentage of Participants With Co-morbidities and/or Co-infections	Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).	Day 0
Other	Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire	The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.	Day 0 and post treatment week 12
Other	Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire	The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem	Day 0 to post treatment week 12
Other	Patient Support Program (PSP) Utilization and Satisfaction Assessment	The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.	Up to 24 weeks of treatment
Other	Percentage of Participants With Adherence to Planned RBV Target Dose Taken	Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%.	Up to 24 weeks of treatment
Other	Percentage of Participants Deviating From the Target ABBVIE Regimen Duration	Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.	Up to 24 weeks of treatment
Other	Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken	Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%.	Up to 24 weeks of treatment
Primary	Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	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.	12 Weeks after the last dose of study drug
Secondary	Percentage of Participants With Virological Response at End of Treatment (EoTR)	The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]).	Up to 24 weeks of treatment
Secondary	Percentage of Participants With On-treatment Virologic Failure (Breakthrough)	The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]).	Up to approximately 24 weeks
Secondary	Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)	SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).	12 weeks after last dose of study drug
Secondary	Percentage of Participants With Post-treatment Relapse	The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA =50 IU/mL)	Up to 12 weeks after last dose of study drug

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