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: June 21, 2016
Last verified: June 2016
  Purpose
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.

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:
  • 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 ]

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 ]

Biospecimen Retention:   Samples Without DNA
Plasma

Estimated Enrollment: 650
Study Start Date: December 2011
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead OAV in a previous Gilead-sponsored HCV 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:

  • 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
  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 382 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Theo Brandt-Sarif, MD Gilead Sciences
  More Information

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: June 21, 2016
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 22, 2016