- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103699
A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
February 19, 2016 updated by: Janssen Scientific Affairs, LLC
A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings
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).
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
315
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
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California
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Florida
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Daytona Beach, Florida, United States
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Deland, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Kentucky
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Crestview Hills, Kentucky, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Springfield, Massachusetts, United States
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New Jersey
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Newark, New Jersey, United States
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Vineland, New Jersey, United States
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New York
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Brooklyn, New York, United States
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Flushing, New York, United States
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New York, New York, United States
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Ny, New York, United States
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North Carolina
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Statesville, North Carolina, United States
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Winston Salem, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Doylestown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Utah
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Murray, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hepatitis C virus (HCV) infected patients receiving simeprevir.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Hepatitis C virus infected patients receiving simeprevir
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients who Achieve Sustained Virologic Response(SVR)
Time Frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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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.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of Prognostic Factors of Virologic Response
Time Frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Prognostic factors of virologic response includes patient and disease characteristics, treatment paradigm, Rapid Virologic Response (RVR), and select practice setting features.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Total duration of therapy
Time Frame: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Discontinue Therapy by reason
Time Frame: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Rapid Virologic Response (RVR)
Time Frame: Week 4
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RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
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Week 4
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Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
Time Frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment.
RVR is defined as undetectable HCV RNA at Week 4. Actual end of treatment will be determined by health care provider.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
Time Frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With On-treatment Virologic Failure
Time Frame: Up to actual end of treatment (an expected average of up to 2 years)
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On-treatment virologic failure is defined as a confirmed increase of >1 log10 IU/mL in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in patients whose HCV RNA had previously been <25 IU/mL.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Viral Relapse
Time Frame: Up to actual end of treatment (an expected average of up to 2 years)
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Viral Relapse is defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) after concluding treatment with undetectable HCV RNA.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Events by Grade and Causality
Time Frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
Time Frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Event Determined to be Related to Simeprevir
Time Frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Serious Adverse Event
Time Frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Develop Mutations at the Time of Virologic Failure
Time Frame: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
February 18, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
February 19, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR101973
- TMC435HPC4003 (Other Identifier: Janssen Scientific Affairs, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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