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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)
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.
This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file. This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes: * 12-week treatment regimen: four visits plus two interim data collection windows * 24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fundacion Cardioinfantil
Bogotá, Colombia
Cic Cali
Cali, Colombia
Centro Medico lmbanaco de Cali I
Cali, Colombia
Pharos Centro de Estudios Clin
Cartagena, Colombia
IPS Medicos Internistas Del Ca I
Manizales, Colombia
Fundacion Hospitalaria San Vin
Medellín, Colombia
Start Date
February 23, 2017
Primary Completion Date
August 30, 2018
Completion Date
August 30, 2018
Last Updated
September 18, 2019
66
ACTUAL participants
Lead Sponsor
AbbVie
NCT00199719
NCT06922643
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03612973