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

Completed
Conditions
Hepatitis C, Chronic
Registration Number
NCT01457768
Lead Sponsor
Gilead Sciences
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
570
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of participants with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimenUp to 3 years
Secondary Outcome Measures
NameTimeMethod
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimenUp to 3 years
Average number of DRM loss by treatment regimenUp to 3 years
Liver disease progressionUp 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 regimenUp to 144 weeks

Trial Locations

Locations (310)

Birmingham Gastroenterology Associates

🇺🇸

Birmingham, Alabama, United States

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Digestive Health Specialists

🇺🇸

Tupelo, Mississippi, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

University of Arizona

🇺🇸

Tucson, Arizona, United States

Advanced Clinical Research Institute, LLC

🇺🇸

Anaheim, California, United States

Franco Felizarta, MD

🇺🇸

Bakersfield, California, United States

Southern California Medical Group

🇺🇸

Coronado, California, United States

West Coast Clinical Trials, LLC

🇺🇸

Costa Mesa, California, United States

UC Davis Medical Center

🇺🇸

Sacramento, California, United States

Scroll for more (300 remaining)
Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States

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