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Trial record 3 of 8 for:    Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

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: NCT02798315
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : December 31, 2018
Last Update Posted : December 31, 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 Kuwait in a clinical practice patient population.


Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 40 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 Kuwait
Actual Study Start Date : May 25, 2016
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Participants With Hepatitis C Virus (HCV) Genotype 1 or 4

Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV.

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 Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug


Secondary Outcome Measures :
  1. Percentage of Participants With Virological Response at End of Treatment (EoT) [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Virological response defined as HCV RNA level less than 50 IU/mL.

  2. Percentage of Participants With Relapse at EoT [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.

  3. Percentage of Participants With Breakthrough. [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.

  4. Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).

  5. Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.

  6. Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA [ Time Frame: Up to 48 weeks ]
    Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.

  7. Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV [ Time Frame: Up to 48 weeks ]
    Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.

  8. Adherence: Percentage of Planned Duration of RBV Taken by Participant [ Time Frame: Up to 48 weeks ]
  9. Change From Baseline in the PAM-13 Questionnaire [ Time Frame: Up to 48 weeks ]
    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). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health.

  10. Patient Support Program (PSP) Questionnaire: Utilization of PSP Components [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).



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
Participants with CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.
Criteria

Inclusion Criteria:

  • Treatment-naïve or -experienced adult male or female participants 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 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).
  • Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

  • Participant must not be participating or attending in a concurrent interventional therapeutic trial.

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): NCT02798315


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Hany Salaheldine, MD AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] September 30, 2016
Statistical Analysis Plan  [PDF] July 18, 2017


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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02798315     History of Changes
Other Study ID Numbers: P15-699
First Posted: June 14, 2016    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: December 31, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by AbbVie:
Paritaprevir/r - Ombitasvir, ± Dasabuvir
Sustained Virological Response
Chronic Hepatitis C genotype 4
Observational Study
Chronic Hepatitis C genotype 1
Chronic Hepatitis C

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents