Gilead Sustained Virologic Response (SVR) Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01457755
First received: October 4, 2011
Last updated: August 11, 2014
Last verified: August 2014

October 4, 2011
August 11, 2014
September 2011
July 2023   (final data collection date for primary outcome measure)
Sustained Virologic Response [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study
Same as current
Complete list of historical versions of study NCT01457755 on ClinicalTrials.gov Archive Site
  • Subsequent detection of HCV RNA [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR, represents the re emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection
  • 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, symptoms and laboratory parameters including alfa-feto protein.
  • Subsequent detection of HCV RNA [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR, represents the re emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection
  • Clinical Progression of liver disease [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Clinical progression of liver disease will be assesssed 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, symptoms and laboratory parameters including alfa-feto protein.
Exploratory Objective [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess quality of life following treatment in a Gilead-Sponsored Hepatitis C study
Not Provided
 
Gilead Sustained Virologic Response (SVR) Registry
A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored HCV study.

Hepatitis C, Chronic
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
4000
July 2023
July 2023   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
  • Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
  • Provide written, informed consent
  • Be willing and able to comply with the visit schedule and protocol-mandated procedures.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States,   Netherlands,   Germany,   New Zealand,   Spain,   Italy,   United Kingdom,   France,   Puerto Rico,   Canada,   Poland,   Czech Republic,   Austria,   Sweden,   Estonia
 
NCT01457755
GS-US-248-0122, 2011-000945-19
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John McNally Gilead Sciences
Gilead Sciences
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP