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Gilead Sustained Virologic Response (SVR) Registry

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ClinicalTrials.gov Identifier: NCT01457755
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This Registry is designed to provide long term clinical and virologic follow up in participants 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.

Condition or disease
Hepatitis C, Chronic

Study Design
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Study Type : Observational
Actual Enrollment : 6625 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 13, 2012
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants maintaining SVR at Week 144 by treatment regimen [ Time Frame: Week 144 ]

Secondary Outcome Measures :
  1. Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
  2. Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
  3. Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen [ Time Frame: Up to 144 weeks ]
  4. Liver disease progression [ Time Frame: Up to 144 weeks ]
    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.

  5. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have achieved sustained virologic response (SVR) while participating 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 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

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
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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): NCT01457755


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01457755    
Other Study ID Numbers: GS-US-248-0122
2011-000945-19 ( EudraCT Number )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
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
GS 7977
GS 5816
Sofosbuvir
Sovaldi™
SOF
Ledipasvir
LDV
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes