Clinical trial NCT02103699: A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Keywords: Hepatitis C virus
Simeprevir
Ribonucleic acid
Sustained virologic response
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C virus (HCV) infected patients receiving simeprevir.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients who Achieve Sustained Virologic Response(SVR)
timeFrame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Secondary outcomes:
measure: Determination of Prognostic Factors of Virologic Response
timeFrame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Total duration of therapy
timeFrame: Up to actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients who Discontinue Therapy by reason
timeFrame: Up to actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients who Achieve Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
timeFrame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
timeFrame: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With On-treatment Virologic Failure
timeFrame: Up to actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With Viral Relapse
timeFrame: Up to actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With Adverse Events by Grade and Causality
timeFrame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
timeFrame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With Adverse Event Determined to be Related to Simeprevir
timeFrame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients With Serious Adverse Event
timeFrame: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
measure: Number of Patients who Develop Mutations at the Time of Virologic Failure
timeFrame: Up to actual end of treatment (an expected average of up to 2 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Daytona Beach
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Crestview Hills
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Newark
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Ny
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Rocky Mount
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Doylestown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: