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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798315
• Other study ID #: P15-699
• Status: Completed
• Start date: May 25, 2016
• Est. completion date: June 12, 2017

Study information

• Verified date: June 2017
• 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 Kuwait in a clinical practice patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

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 Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug	12 weeks (i.e. at least 70 days) after the last dose of study drug
Secondary	Percentage of Participants With Virological Response at End of Treatment (EoT)	Virological response defined as HCV RNA level less than 50 IU/mL.	Up to EoT, maximum of 24 weeks
Secondary	Percentage of Participants With Relapse at EoT	Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.	Up to EoT, maximum of 24 weeks
Secondary	Percentage of Participants With Breakthrough.	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.	Up to EoT, maximum of 24 weeks
Secondary	Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse	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).	12 weeks (i.e. at least 70 days) after the last dose of study drug
Secondary	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	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.	12 weeks (i.e. at least 70 days) after the last dose of study drug
Secondary	Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA	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.	Up to 48 weeks
Secondary	Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV	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.	Up to 48 weeks
Secondary	Adherence: Percentage of Planned Duration of RBV Taken by Participant		Up to 48 weeks
Secondary	Change From Baseline in the PAM-13 Questionnaire	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.	Up to 48 weeks
Secondary	Patient Support Program (PSP) Questionnaire: Utilization of PSP Components	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).	Up to EoT, maximum of 24 weeks