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

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ClinicalTrials.gov Identifier: NCT01457768
Recruitment Status : Active, not recruiting
First Posted : October 24, 2011
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hepatitis C, Chronic

Study Design

Study Type : Observational
Actual Enrollment : 570 participants
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
Actual Study Start Date : December 19, 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen [ Time Frame: Up to 3 years ]
  2. Average number of DRM loss by treatment regimen [ Time Frame: Up to 3 years ]
  3. Liver disease progression [ Time Frame: Up to 3 years ]
    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.

  4. Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]

Biospecimen Retention:   Samples Without DNA
Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457768


  Show 323 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director 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 ( EudraCT Number )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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