Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
VERITAS
2 other identifiers
observational
244
0 countries
N/A
Brief Summary
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2018
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedJuly 26, 2019
January 1, 2019
2.5 years
December 16, 2015
May 23, 2019
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.
12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
Secondary Outcomes (20)
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)
24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
Percentage of Participants Achieving Virological Response at End of Treatment
End of treatment (week 12 or 24 depending on the treatment regimen)
Percentage of Participants With Relapse
End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
Number of Participants With Breakthrough
12 or 24 weeks (depending on the treatment regimen)
Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment
12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
- +15 more secondary outcomes
Study Arms (1)
Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin
Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.
Eligibility Criteria
Chronic Hepatitis C (CHC)
You may qualify if:
- Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
- If RBV is co-administered with the PTV/r+OBV±DSV±RBV, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
- Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- IST GmbH, Germanycollaborator
Related Publications (1)
Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
PMID: 30739368DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 22, 2015
Study Start
November 27, 2015
Primary Completion
May 23, 2018
Study Completion
May 23, 2018
Last Updated
July 26, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-01