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: August 11, 2014
Last verified: August 2014
This Registry is designed to obtain long term data on subject 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 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:
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Clinical progression of liver disease [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Screening for the development of HCC will comprise of review of clinical signs and symptoms and laboratory parameters including alfa-feto protein.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2023 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored hepatitis C 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.
- Subject plans 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 subject 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
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2011
||August 11, 2014
||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 November 25, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections