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Completed

NCT Number: NCT01457755

Gilead Sustained Virologic Response (SVR) Registry

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Canberra Specialist Centre, Canberra, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of participants maintaining SVR at Week 144 by treatment regimen

    Time frame: Week 144

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Oct 24, 2011
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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