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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)

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ClinicalTrials.gov Identifier: NCT02615145
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date November 24, 2015
First Posted Date November 26, 2015
Last Update Posted Date April 12, 2018
Actual Study Start Date December 3, 2015
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2015)
Percentage of Participants with Sustained Virologic Response (SVR12) [ Time Frame: 12 weeks after the last dose of study drug ]
Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02615145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 12, 2018)
  • Change in Participants Burden of Suffering Measured with The Pictorial Representation of Illness and Self-Measure (PRISM) tool [ Time Frame: Day 0 to post treatment week 12 ]
  • Percentage of Participants with Relapse or Reinfection [ Time Frame: Up to post treatment week 48 ]
    Relapse is defined as (detectable viral load at SVR12) or reinfection (detectable viral load after achieving SVR12 until post treatment week 48)
  • Usage Pattern of Treatment Regimen [ Time Frame: Up to post treatment week 12 ]
    Case report form collection will evaluate the usage pattern of the treatment regimen
  • Adherence of Participants Per Questionnaire [ Time Frame: Day 0 to post treatment week 12 ]
  • Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale [ Time Frame: From week 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 ]
    Questionnaire measures patient knowledge, skill and confidence for self-management
  • 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 ]
    Questionnaire measures work time missed, work and non-work activity impairment due to a specified healthy problem during the past seven days.
Original Secondary Outcome Measures
 (submitted: November 24, 2015)
  • Patient Support Program (PSP) Utilization and Satisfaction Assessment [ Time Frame: Up to post-treatment week 12 ]
    Questionnaire to evaluate the utilization of the patient-support-program in percent and effect of participation on treatment-effectiveness; patient satisfaction with PSP
  • Evaluate the Usage Pattern of the Treatment Regimen [ Time Frame: Up to post treatment week 12 ]
    Case report form collection
  • Adherence of Participants Per 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 ]
    Questionnaire measures patient knowledge, skill and confidence for self-management
  • Percentage of Participants with Relapse or Reinfection [ Time Frame: Up to post treatment week 48 ]
    Relapse is defined as (detectable viral load at SVR12) or reinfection (detectable viral load after achieving SVR12 until post treatment week 48)
  • Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale [ Time Frame: From week 0 to post treatment week 12 ]
  • 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 ]
    Questionnaire measures work time missed, work and non-work activity impairment due to a specified healthy problem during the past seven days.
  • Change in Participants Burden of Suffering Measured with The Pictorial Representation of Illness and Self-Measure (PRISM) tool [ Time Frame: Day 0 to post treatment week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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)
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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chronic Hepatitis C (CHC)
Condition Chronic Hepatitis C
Intervention Not Provided
Study Groups/Cohorts
  • GT4 participants treated with Ribavirin
    GT4 participants receiving Ombitasvir+Paritaprevir+Ritonavir+Ribavirin
  • GT1 participants treated with Ribavirin
    GT1 participants receiving Dasabuvir+ Ombitasvir+Paritaprevir+Ritonavir + Ribavirin
  • Genotype 1 (GT1) participants treated without Ribavirin
    GT1 participants receiving Dasabuvir+ Ombitasvir+Paritaprevir+Ritonavir
  • Genotype 4 (GT4) participants treated without Ribavirin
    GT4 participants receiving Ombitasvir+Paritaprevir+Ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2018)
472
Original Estimated Enrollment
 (submitted: November 24, 2015)
1000
Actual Study Completion Date March 26, 2018
Actual Primary Completion Date March 26, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02615145
Other Study ID Numbers P15-398
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2018