CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 4
  • Confirmed chronic hepatitis C, genotype 1
  • Adult male or female
  • Treatment-naïve or treatment-experienced
  • Receiving paritaprevir/ritonavir/ombitasvir ± dasabuvir ± ribavirin per standard of care and local label
Key exclusion· 1
  • Participating in or intending to participate in a concurrent interventional therapeutic trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02851069
NCT02851069N/ACompleted

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)

AbbVie·observational·Posted Aug 1, 2016·Updated Sep 18, 2019

In Brief

An observational study for Chronic Hepatitis C. Completed, enrolled 66 participants across 6 sites.

Detailed Summary

This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label. This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesColombia
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 1, 2016
Enrollment StartFeb 23, 2017
Primary CompletionAug 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.9 years ago