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A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir

Hepatitis C Virus Clinical Trial

Official title:
A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).

Clinical Trial Description

This is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice. Approximately 300 Hepatitis C virus (HCV) infected patients who are prescribed simeprevir by their health care provider as part of their routine HCV treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir. Practice setting features will be documented at the initiation of the study by each participating site. The decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving. All treatment decisions will be made at the discretion of the health care provider. Safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests). The maximum study duration for each patient will be approximately 2 years. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02103699
Study type Observational
Source Janssen Scientific Affairs, LLC
Contact
Status Completed
Phase Phase 4
Start date February 2014
Completion date January 2016
View Details
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