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
2 other identifiers
observational
315
1 country
32
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 22, 2016
February 1, 2016
1.7 years
February 18, 2014
February 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients who Achieve Sustained Virologic Response(SVR)
SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment. Actual end of treatment will be determined by health care provider.
12 weeks after the actual end of treatment (an expected average of up to 2 years)
Secondary Outcomes (13)
Determination of Prognostic Factors of Virologic Response
12 weeks after the actual end of treatment (an expected average of up to 2 years)
Total duration of therapy
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Discontinue Therapy by reason
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Rapid Virologic Response (RVR)
Week 4
Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
12 weeks after the actual end of treatment (an expected average of up to 2 years)
- +8 more secondary outcomes
Study Arms (1)
Hepatitis C virus infected patients receiving simeprevir
Interventions
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.
Eligibility Criteria
Hepatitis C virus (HCV) infected patients receiving simeprevir.
You may qualify if:
- Patients who have genotype 1 chronic hepatitis C infection
- Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
- Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled into the study
- Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
- In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
You may not qualify if:
- Non-genotype 1 HCV infected patients
- Absolute contraindication to any component of prescribed HCV treatment per prescribing information
- Patient is currently enrolled in an interventional study
- Past use of an HCV direct-acting antiviral therapy
- Any investigational drug use within 30 days before initiation of simeprevir-based therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Crestview Hills, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Vineland, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Fayetteville, North Carolina, United States
Unknown Facility
Rocky Mount, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Doylestown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Murray, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2014
First Posted
April 4, 2014
Study Start
February 1, 2014
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
February 22, 2016
Record last verified: 2016-02