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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068963
• Other study ID #: P10433-HCVQPS-01
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: February 2, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Investigative Clinical Research	Annapolis	Maryland
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Austin Center for Clinical Research	Austin	Texas
United States	Central Texas Clinical Research	Austin	Texas
United States	Franco Felizarta, MD	Bakersfield	California
United States	Mercy Medical Center	Baltimore	Maryland
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Charleston GI Specialists	Charleston	South Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	South Denver Gastroenterology, PC	Englewood	Colorado
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Cure C Consortium	Houston	Texas
United States	Liver Associates of Texas, P.A.	Houston	Texas
United States	Research Specialists of Texas	Houston	Texas
United States	Indianapolis Gastroenterology Research Facility	Indianapolis	Indiana
United States	Kansas City Gastroenterology	Kansas City	Missouri
United States	Infectious Diseases Associates of Central Virginia	Lynchburg	Virginia
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Schiff Center for Liver Disease	Miami	Florida
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Quality Medical Research, PLLC	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Inland Empire Liver Foundation	Rialto	California
United States	The Texas Liver Institute	San Antonio	Texas
United States	Kaiser Permanente	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	The Research Institute	Springfield	Massachusetts
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Empire Clinical Research	Upland	California
United States	Island View Gastroenterology	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks post therapy	No