Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
CITRINE
1 other identifier
observational
256
1 country
18
Brief Summary
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ 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 was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2018
CompletedResults Posted
Study results publicly available
October 11, 2019
CompletedOctober 11, 2019
August 1, 2019
2.3 years
June 14, 2016
September 18, 2019
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug.
12 weeks after the last actual dose of study drug
Secondary Outcomes (8)
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Up to 24 weeks
Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment
12 weeks (at least 70 days) after the last actual dose of study drug
Percentage of Participants With Relapse
Up to 48 weeks after the last actual dose of study drug
Percentage of Participants With Viral Breakthrough
Up to 24 weeks
Percentage of Participants With On-treatment Virologic Failure
12 weeks after the last actual dose of study drug
- +3 more secondary outcomes
Study Arms (1)
Participants with HCV genotype 1 or 4
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablets; 1000 or 1200 mg divided twice a day) up to 24 weeks
Interventions
Co-formulated tablet
Supportive services provided to participants included reminder calls, emails, text messages, a Care Coach, and educational/informational materials.
Eligibility Criteria
Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (18)
Soroka Medical Center /ID# 169357
Beersheba, Southern District, 84101, Israel
Rabin Medical Center /ID# 153696
Petakh Tikva, Tel Aviv, 4941492, Israel
Rabin Medical Center /ID# 158648
Petakh Tikva, Tel Aviv, 4941492, Israel
Tel Aviv Sourasky Medical Ctr /ID# 153693
Tel Aviv, Tel Aviv, 6423906, Israel
Ha'Emek Medical Center /ID# 153695
Afula, 18341, Israel
Soroka Medical Ctr /ID# 153697
Beersheba, 84101, Israel
Assaf Harofeh Medical Center /ID# 153708
Be’er Ya‘aqov, 70300, Israel
Maccabi Health Services /ID# 158647
GUSH DAN, 7565016, Israel
Hillel Yaffe Medical Center /ID# 153702
Hadera, 38100, Israel
Rambam Health Care Campus /ID# 153694
Haifa, 3109601, Israel
Bnai Zion Medical Center /ID# 153700
Haifa, 3339419, Israel
The Lady Davis Carmel MC /ID# 153692
Haifa, 3436212, Israel
The Edith Wolfson Medical Cent /ID# 153706
Holon, 58100, Israel
Shaare Zedek Medical Center /ID# 153699
Jerusalem, 91031, Israel
Hadassah /ID# 153701
Jerusalem, 91120, Israel
Meir Medical Center /ID# 153698
Kfar Saba, 44281, Israel
Western Galilee Medical Center /ID# 153705
Nahariya, 22100, Israel
Sheba Medical Center /ID# 153707
Ramat Gan, 5262100, Israel
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
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 16, 2016
Study Start
July 7, 2016
Primary Completion
October 21, 2018
Study Completion
October 21, 2018
Last Updated
October 11, 2019
Results First Posted
October 11, 2019
Record last verified: 2019-08