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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01457768
First received: October 4, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Viral Activity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


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.


Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 800
Study Start Date: September 2011
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.

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.
  Contacts and Locations
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

  Show 334 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John McNally Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01457768     History of Changes
Other Study ID Numbers: GS-US-248-0123, 2011-000946-39
Study First Received: October 4, 2011
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Tegobuvir
Registry
HCV RNA
Treatment experienced
Treatment naive
GS 9451
GS 5885
Sequence
GS 5816
GS 7977
Sofosbuvir
Sovaldi™
SOF
Ledipasvir
LDV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on August 01, 2014