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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

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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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)

  3. 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

  4. Adherence of Participants Per Questionnaire [ Time Frame: Day 0 to post treatment week 12 ]
  5. Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Scale [ Time Frame: From week 0 to post treatment week 12 ]
  6. 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

  7. 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.



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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


Locations
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Germany
Universitatsklinikum Munster
Munster, Niedersachsen, Germany, 48149
Univ Hosp Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
PZB Aachen
Aachen, Germany, 52062
Drs. Brudler, Heinrich und Ban
Augsburg, Germany, 86150
Charité Universitätsmedizin Campus Mitte
Berlin, Germany, 10117
Praxis City Ost
Berlin, Germany, 10243
Praxisgemeinschaft Bieniek
Berlin, Germany, 10243
Carganico, Baumgarten, Dupke
Berlin, Germany, 10439
Gastroenterologie am Bayerisch
Berlin, Germany, 10825
Koeppe, Kreckel, Berlin, DE
Berlin, Germany, 10961
Leberzentrum am Checkpoint
Berlin, Germany, 10969
Praxis Dr. Naumann
Berlin, Germany, 14057
Praxis Dr. Heuchel
Chemnitz, Germany, 09111
Scholten, Cologne, DE
Cologne, Germany, 50674
Zehnter, Dortmund, DE
Dortmund, Germany, 44263
Mauss, Schmutz, Hegener, Athma
Dusseldorf, Germany, 40237
Universitaetsklinikum Essen-
Essen, Germany, 45147
Rambow & Partner, Frankfurt, D
Frankfurt, Germany, 60313
Stern, Frankfurt, DE
Frankfurt, Germany, 60316
Bethanien-Krankenhaus
Frankfurt, Germany, 60389
Praxis Dr. Teuber
Frankfurt, Germany, 60594
Universitaetskl. Gieben u.Marb
Gieben, Germany, 35392
Friese and Cseke, Giessen, DE
Giessen, Germany, 35390
Krankenhausapotheke der Asklepios Kliniken Hamburg GmbH
Hamburg, Germany, 22453
Tappe/Miks/Delker, Hamm, DE
Hamm, Germany, 59065
Praxis Dres. Heiken/Holm/Kuhlm
Hannover, Germany, 30159
Group Practice Gastroenterolog
Herne, Germany, 44623
Moog/Hauenstein, Kassel, DE
Kassel, Germany, 34127
Gastro.-Hepatologisches Zentru
Kiel, Germany, 24146
Zentrum für Innere Medizin
Konstanz, Germany, 78464
Praxis Dr. Schiefke
Leipzig, Germany, 04103
Boerner, Mainz, DE
Mainz, Germany, 55116
Univ Johannes Gutenberg
Mainz, Germany, 55131
Gastro. Schwerpunkt Praxis
Mannheim, Germany, 68161
Medizinische Klinik II
Mannheim, Germany, 68167
Universitatsmedizin Mannheim
Mannheim, Germany, 68167
Praxis Dr. Backmund
Munich, Germany, 80331
Leberzentrum Munich
Munich, Germany, 80336
Centr. für Interdiszipl. Med.
Munster, Germany, 48143
Gastroenterologie
Offenburg, Germany, 77654
Kirchner/Sprenger/Joergensen/S
Remscheid, Germany, 42859
Group Practice, Drs. Schnaitma
Stuttgart, Germany, 70197
Universitatsklinikum Tubingen
Tuebingen, Germany, 72076
Loehr, Wiesbaden, DE
Wiesbaden, Germany, 65185
Zentrum Innere Medizin (ZIM)
Wuerzburg, Germany, 97080
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02615145     History of Changes
Other Study ID Numbers: P15-398
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
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