No intervention
DrugThis is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
NCT Number: NCT02103699
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).
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Notify Me18 year and older
All sexes
Observational
Phoenix, Arizona, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
Time frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Week 4
RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Time frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
Time frame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
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.
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
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.
Time frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Janssen Scientific Affairs, LLC
Industry
A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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