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

Chronic Hepatitis C Clinical Trial

— LIFE-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615145
• Other study ID #: P15-398
• Status: Completed
• Start date: December 3, 2015
• Est. completion date: March 26, 2018

Study information

• Verified date: January 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Treatment-naïve or -experienced 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 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 pseudonymized 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:

• Adolescents; people not treated according to label

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
Primary	Percentage of Participants With Sustained Virologic Response (SVR12)	SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.	12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
Secondary	Percentage of Participants With Virological Response at End of Treatment (EoTR)	Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV.	EoT, (treatment period was 12 weeks or 24 weeks)
Secondary	Number of Participants With On-Treatment Virological Failure or Relapse	The number of participants meeting the following SVR12 non-response categories: On-treatment virological failure (breakthrough) defined >= 1 documented HCV RNA < 50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value >= 50 IU/mL); Relapse defined as HCV RNA < 50 IU/mL at EoT followed by HCV RNA >= 50 IU/mL post-treatment in participants who completed treatment (<= 7 days shortened).	Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
Secondary	Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)	RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4.	Week 4
Secondary	Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)	SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT.	24 Weeks After EoT (treatment period was 12 or 24 weeks)
Secondary	Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)	SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT.	48 Weeks After EoT (treatment period was 12 or 24 weeks)
Secondary	Change From Baseline in PRISM Over Time	PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the "self" (yellow disk) and the illness disk (red disk) is called "self-illness separation" (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering.	Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
Secondary	Percentage of Participants With = 1 Comorbidity and/or Co-Infection		up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Secondary	Percentage of Participants Taking = 1 Co-Medication		up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
Secondary	Mean Duration of of ABBVIE REGIMEN and RBV Taken	Documented by participant interview and/or participant diary.	Up to Week 12 or Week 24
Secondary	Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken	Planned duration of treatment was 12 or 24 weeks.	Up to Week 12 or Week 24
Secondary	Change From Baseline in FACIT-F Scale Over Time	The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue.	Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
Secondary	Change From Baseline to EoT in PAM-13 Questionnaire	The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence.	Baseline, EoT (treatment period was 12 or 24 weeks)
Secondary	Change From Baseline Over Time in WPAI: Total Work Productivity Impairment	The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.; Total work productivity impairment indicates the percentage of overall work impairment due to health problems.	Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Secondary	Change From Baseline Over Time in WPAI: Total Activity Impairment	The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.; Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems.	Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies	An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing.	up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)

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