Hepatitis CNCT02068963
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
An observational study of Hepatitis C, run by Hologic, Inc. at 34 sites in 2 countries.
Trial summary
This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 352 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Feb 2014to Dec 2015
- 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: Treatment naïve men and women ≥18 years of age with chronic HCV infection initiating sofosbuvir-based treatment will be enrolled from medical facilities that may include private and academic family practice, infectious disease, hepatology, gastroenterology, and medical group clinics.
Who may be able to join
- The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to HCV treatment (treatment naïve).
- Chronic HCV (with or without HIV [human immunodeficiency virus] co-infection) will be documented with historical record of:
- A positive HCV RNA test result (result generated at least 6 months before the baseline visit)
- A HCV genotype test result (result generated at least 6 months before the baseline visit)
- A liver biopsy report demonstrating chronic HCV
- ---The subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
Show all 12Show fewer
- Sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
- Sofosbuvir plus ribavirin for 12 weeks (genotype 2)
- Sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
- The subject is at least 18 years of age at the time of enrollment
- Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
- The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
Who cannot join
- Subjects with history or evidence of decompensated liver disease
- Subjects with severe renal impairment or end stage renal disease
- Subjects who are not naïve to HCV therapy with prior exposure to an approved or experimental HCV antiviral therapy
- Subject has characteristics that are contraindicated in the FDA approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package Insert 2013)
- Subject is receiving treatment pre- or post-transplant
- Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
- Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States33 sites
Investigative Clinical Research
Annapolis, Maryland, 21401
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308
Central Texas Clinical Research
Austin, Texas, 78705
Austin Center for Clinical Research
Austin, Texas, 78756
Franco Felizarta, MD
Bakersfield, California, 93301
Mercy Medical Center
Baltimore, Maryland, 21202
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Charleston GI Specialists
Charleston, South Carolina, 29414
Duke University Medical Center
Durham, North Carolina, 27710
South Denver Gastroenterology, PC
Englewood, Colorado, 80113
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
Cure C Consortium
Houston, Texas, 77004
Liver Associates of Texas, P.A.
Houston, Texas, 77030
Research Specialists of Texas
Houston, Texas, 77030
Indianapolis Gastroenterology Research Facility
Indianapolis, Indiana, 46237
Kansas City Gastroenterology
Kansas City, Missouri, 64131
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Schiff Center for Liver Disease
Miami, Florida, 33136
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Quality Medical Research, PLLC
Nashville, Tennessee, 37211
Yale School of Medicine
New Haven, Connecticut, 06510
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Inland Empire Liver Foundation
Rialto, California, 92377
The Texas Liver Institute
San Antonio, Texas, 78215
Kaiser Permanente
San Francisco, California, 94118
University of Washington
Seattle, Washington, 98104
The Research Institute
Springfield, Massachusetts, 01105
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Empire Clinical Research
Upland, California, 91786
Island View Gastroenterology
Ventura, California, 93003
About this study
Official title: Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay
This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response based on lower limit of quantitation
Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
Measured: 12 weeks post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Kuslich, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068963
- Sponsor's protocol ID
- P10433-HCVQPS-01
- Status last verified
- Feb 2016
- First submitted
- 14 Feb 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay
- ClinicalTrials.gov ID
- NCT02068963
- Acronym / sponsor ID
- P10433-HCVQPS-01
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Feb 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.
This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naïve men and women ≥18 years of age with chronic HCV infection initiating sofosbuvir-based treatment will be enrolled from medical facilities that may include private and academic family practice, infectious disease, hepatology, gastroenterology, and medical group clinics.
Key inclusion criteria (12 listed)
- The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to HCV treatment (treatment naïve).
- Chronic HCV (with or without HIV [human immunodeficiency virus] co-infection) will be documented with historical record of:
- A positive HCV RNA test result (result generated at least 6 months before the baseline visit)
- A HCV genotype test result (result generated at least 6 months before the baseline visit)
- A liver biopsy report demonstrating chronic HCV
Key exclusion criteria (7 listed)
- Subjects with history or evidence of decompensated liver disease
- Subjects with severe renal impairment or end stage renal disease
- Subjects who are not naïve to HCV therapy with prior exposure to an approved or experimental HCV antiviral therapy
- Subject has characteristics that are contraindicated in the FDA approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package Insert 2013)
- Subject is receiving treatment pre- or post-transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained viral response based on lower limit of quantitation
Time frame: 12 weeks post therapy
Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
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 4 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.
Christine Kuslich study director
Hologic, Inc.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Hologic, Inc. at 34 sites in 2 countries.
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 12 inclusion and 7 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 4 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 34 sites in United States, Puerto Rico. 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?
Sustained viral response based on lower limit of quantitation (time frame: 12 weeks post therapy). 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 4 Feb 2016.