A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

• ClinicalTrials.gov Identifier: NCT01457768
• Recruitment Status: Completed
• First Posted: October 24, 2011
• Last Update Posted: May 4, 2018
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Tracking Information

• First Submitted Date: October 4, 2011
• First Posted Date: October 24, 2011
• Last Update Posted Date: May 4, 2018
• Actual Study Start Date: December 19, 2011
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 8, 2014): Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen [ Time Frame: Up to 3 years ]

Original Primary Outcome Measures (submitted: October 20, 2011)

Viral Activity [ Time Frame: 3 years ]

To characterize HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral (OAV) containing regimen in a previous Gilead-sponsored hepatitis C study

Current Secondary Outcome Measures (submitted: December 8, 2014)

• Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen [ Time Frame: Up to 3 years ]
• Average number of DRM loss by treatment regimen [ Time Frame: Up to 3 years ]
• Liver disease progression [ Time Frame: Up to 3 years ]
  Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
• Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]

Original Secondary Outcome Measures (submitted: October 20, 2011)

• Clinical progression of liver disease [ Time Frame: 3 years ]
  Clinical progression of liver disease will be assessed by review of clinical signs, symptoms and laboratory parameters (clinical chemistry, haematology, coagulation and alfa-feto protein).
• Development of hepatocellular carcinoma (HCC) [ Time Frame: 3 years ]
  Screening for the development of HCC will comprise of review of clinical signs and symptoms and laboratory parameters including alfa-feto protein.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
• Official Title: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
• Brief Summary: This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Plasma

• Sampling Method: Non-Probability Sample
• Study Population: Participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored HCV study.
• Condition: Hepatitis C, Chronic
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.
• Younossi ZM, Stepanova M, Jacobson I, Muir AJ, Pol S, Zeuzem S, Younes Z, Herring R, Lawitz E, Younossi I, Racila A. Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):628-632. doi: 10.1093/cid/ciz243.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 13, 2017): 570
• Original Estimated Enrollment (submitted: October 20, 2011): 600
• Actual Study Completion Date: April 9, 2018
• Actual Primary Completion Date: April 9, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV
• Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol
• Provide written, informed consent
• Be willing and able to comply with the visit schedule

Key Exclusion Criteria:

• Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry
• History of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01457768
• Other Study ID Numbers: GS-US-248-0123; 2011-000946-39 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gilead Sciences
• Study Sponsor: Gilead Sciences
• Collaborators: Not Provided

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

• PRS Account: Gilead Sciences
• Verification Date: May 2018