Clinical trial NCT02817594: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis 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 The Netherlands (3DUTCH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Paritaprevir/r - Ombitasvir, ± Dasabuvir
Sustained Virological Response
Observational Study
Chronic Hepatitis C genotype 1
Chronic Hepatitis C genotype 4
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN will be offered the opportunity to participate in this study during a routine clinical visit at the participating sites.

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 the Netherlands in a clinical practice patient population.


Eligibility 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).
* Participants must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

* Patients participating or intending to participate in a concurrent interventional therapeutic trial.
* Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
* Unable to complete the questionnaires due to language incompetence.
* Unable to voluntarily sign and date the informed consent.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary outcomes:
measure: Percentage of Participants Achieving Virological Response at End of Treatment
timeFrame: End of treatment (week 12 or 24 depending on the treatment regimen)
measure: Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment
timeFrame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
measure: Percentage of Participants With Relapse
timeFrame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
measure: Percentage of Participants With Breakthrough
timeFrame: 12 or 24 weeks (depending on the treatment regimen)
measure: Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
timeFrame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
measure: Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
measure: Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
measure: Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days
timeFrame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
measure: Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies
timeFrame: From first dose of study drug through 30 days after last dose (16 weeks).
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism
timeFrame: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
Other outcomes:
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis /ID# 152597
state: Zuid-Holland
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep /ID# 152604
city: Amsterdam
country: Netherlands
facility: Duplicate_Onze Lieve Vrouwe Gasthuis /ID# 152600
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 152596
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum /ID# 154637
city: Nijmegen
country: Netherlands
facility: Radbound University Medical Ce /ID# 152598
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 154635
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis /ID# 152592
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 152595
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: