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Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02068963
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.

Brief 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. 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.

Condition or disease
Hepatitis C

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Study Type : Observational
Actual Enrollment : 352 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Study Population



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma and serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068963


Locations
Show Show 34 study locations
Sponsors and Collaborators
Hologic, Inc.
Investigators
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Study Director: Christine Kuslich Hologic, Inc.
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Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT02068963    
Other Study ID Numbers: P10433-HCVQPS-01
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic