NCT02103699

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 315 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2014-04-04
• Last updated: 2016-02-22

Locations

32 sites across 1 country: United States