Hepatitis C VirusNCT02103699
A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
An observational study of Hepatitis C Virus, run by Janssen Scientific Affairs, LLC at 32 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus
- Type of treatment
- Pill or oral medicine
- How many people
- 315 participants
- Where
- 32 sitesUnited States
- Study dates
- Feb 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatitis C virus (HCV) infected patients receiving simeprevir.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Brooklyn, New York
Study site
Cincinnati, Ohio
Study site
Crestview Hills, Kentucky
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
DeLand, Florida
Study site
Doylestown, Pennsylvania
Study site
Durham, North Carolina
Study site
Fayetteville, North Carolina
Study site
Flushing, New York
Study site
Fort Worth, Texas
Study site
Houston, Texas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Murray, Utah
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Norfolk, Virginia
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Rocky Mount, North Carolina
Study site
Springfield, Massachusetts
Study site
Statesville, North Carolina
Study site
Tampa, Florida
Study site
Vineland, New Jersey
Study site
West Palm Beach, Florida
Study site
Winston-Salem, North Carolina
About this study
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
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).
Read the 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
- Being tested
- No intervention
- Keywords
- Hepatitis C virus, Simeprevir, Ribonucleic acid, Sustained virologic response
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C virus infected patients receiving simeprevir | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Total duration of therapy
Actual end of treatment will be determined by health care provider.
Measured: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Discontinue Therapy by reason
Actual end of treatment will be determined by health care provider.
Measured: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Rapid Virologic Response (RVR)
RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Measured: Week 4
Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
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.
Measured: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
Actual end of treatment will be determined by health care provider.
Measured: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With On-treatment Virologic Failure
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.
Measured: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients With Viral Relapse
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.
Measured: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients With Adverse Events by Grade and Causality
Actual end of treatment will be determined by health care provider.
Measured: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
Actual end of treatment will be determined by health care provider.
Measured: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Adverse Event Determined to be Related to Simeprevir
Actual end of treatment will be determined by health care provider.
Measured: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Serious Adverse Event
Actual end of treatment will be determined by health care provider.
Measured: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients who Develop Mutations at the Time of Virologic Failure
Actual end of treatment will be determined by health care provider.
Measured: Up to actual end of treatment (an expected average of up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103699
- Sponsor's protocol ID
- CR101973
- Other IDs
- TMC435HPC4003
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02103699
- Acronym / sponsor ID
- CR101973
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C virus, Simeprevir, Ribonucleic acid, Sustained virologic response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C virus infected patients receiving simeprevir | – | Drug: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis C virus (HCV) infected patients receiving simeprevir.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed. | Drug | Hepatitis C virus infected patients receiving simeprevir |
Primary outcome
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)
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.
13 secondary outcomes
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)
Total duration of therapy
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Discontinue Therapy by reason
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Rapid Virologic Response (RVR)
Time frame: Week 4
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)
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)
Number of Patients With On-treatment Virologic Failure
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients With Viral Relapse
Time frame: Up to actual end of treatment (an expected average of up to 2 years)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by Janssen Scientific Affairs, LLC at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.