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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) (LIFE-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615145
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.


Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 472 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Genotype 1a (G1a) Participants

Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 1b (G1b) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 [G4]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 4 (G4) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR12) [ Time Frame: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Virological Response at End of Treatment (EoTR) [ Time Frame: EoT, (treatment period was 12 weeks or 24 weeks) ]
    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.

  2. Number of Participants With On-Treatment Virological Failure or Relapse [ Time Frame: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks) ]

    The number of participants meeting the following SVR12 non-response categories:

    1. 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)
    2. 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).

  3. Percentage of Participants With Rapid Virological Response at Week 4 (RVR4) [ Time Frame: Week 4 ]
    RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4.

  4. Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24) [ Time Frame: 24 Weeks After EoT (treatment period was 12 or 24 weeks) ]
    SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT.

  5. Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48) [ Time Frame: 48 Weeks After EoT (treatment period was 12 or 24 weeks) ]
    SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT.

  6. Change From Baseline in PRISM Over Time [ Time Frame: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks) ]
    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.

  7. Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection [ Time Frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks) ]
  8. Percentage of Participants Taking ≥ 1 Co-Medication [ Time Frame: up to post-treatment Week 48 (treatment period was 12 or 24 weeks) ]
  9. Mean Duration of of ABBVIE REGIMEN and RBV Taken [ Time Frame: Up to Week 12 or Week 24 ]
    Documented by participant interview and/or participant diary.

  10. Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken [ Time Frame: Up to Week 12 or Week 24 ]
    Planned duration of treatment was 12 or 24 weeks.

  11. Change From Baseline in FACIT-F Scale Over Time [ Time Frame: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT ]
    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.

  12. Change From Baseline to EoT in PAM-13 Questionnaire [ Time Frame: Baseline, EoT (treatment period was 12 or 24 weeks) ]
    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.

  13. Change From Baseline Over Time in WPAI: Total Work Productivity Impairment [ Time Frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT ]

    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.


  14. Change From Baseline Over Time in WPAI: Total Activity Impairment [ Time Frame: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT ]

    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.


  15. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies [ Time Frame: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Hepatitis C (CHC)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615145


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] November 17, 2016
Statistical Analysis Plan  [PDF] December 18, 2017


Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02615145    
Other Study ID Numbers: P15-398
First Posted: November 26, 2015    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Hepatitis C
Dasabuvir
Ombitasvir+Paritaprevir+Ritonavir
Observational Study
Quality of life
Work-ability
Fibrosis
Cirrhosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors