Status:
COMPLETED
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
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...
Detailed Description
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. The prescription of a treatment regimen was at the discretion of ...
Eligibility Criteria
Inclusion
- Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
- If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
- Exclusion Criteria:
- \- None
Exclusion
Key Trial Info
Start Date :
July 7 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 21 2018
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT02803138
Start Date
July 7 2016
End Date
October 21 2018
Last Update
October 11 2019
Active Locations (18)
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1
Soroka Medical Center /ID# 169357
Beersheba, Southern District, Israel, 84101
2
Rabin Medical Center /ID# 153696
Petakh Tikva, Tel Aviv, Israel, 4941492
3
Rabin Medical Center /ID# 158648
Petakh Tikva, Tel Aviv, Israel, 4941492
4
Tel Aviv Sourasky Medical Ctr /ID# 153693
Tel Aviv, Tel Aviv, Israel, 6423906