A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: October 4, 2011
Last updated: March 12, 2015
Last verified: March 2015
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Average number of DRM loss by treatment regimen [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Liver disease progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2019 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored HCV study.
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457768
||Theo Brandt-Sarif, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2011
||March 12, 2015
||United States: Food and Drug Administration
Keywords provided by Gilead Sciences:
Sustained Virologic Response
Direct Acting Antiviral
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 31, 2015
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections