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A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02292706
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This Registry will enroll participants with cirrhosis with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

Condition or disease Intervention/treatment
Hepatitis C Virus Infection Drug: Sofosbuvir

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1609 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Actual Study Start Date : December 29, 2014
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Groups and Cohorts
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Intervention Details:
  • Drug: Sofosbuvir
    Exposure of interest for participants who received a sofosbuvir-based regimen in a previous Gilead study for chronic hepatitis C virus infection.
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants maintaining sustained virologic response (SVR) at Week 240 [ Time Frame: Week 240 ]
  2. Proportion of participants who develop liver disease progression or regression, as assessed by clinical and laboratory parameters [ Time Frame: Up to 240 weeks ]
  3. Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 240 [ Time Frame: Up to 240 weeks ]

Secondary Outcome Measures :
  1. Proportion of participants with detectable HCV RNA due to re-emergence of pre-existing virus through Week 240 [ Time Frame: Up to 240 weeks ]
  2. Proportion of participants with detectable HCV resistance mutations through Week 240 [ Time Frame: Up to 240 weeks ]
  3. Proportion of participants with detectable HCV RNA due to re-infection through Week 240 [ Time Frame: Up to 240 weeks ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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 with cirrhosis who have achieved an SVR after receiving a SOF-based regimen without IFN while participating in a Gilead-sponsored HCV study. In addition, participants with cirrhosis who have achieved SVR after an all-oral SOF-based regimen outside a clinical study may be eligible to enroll in this registry at sites preselected by Gilead.
Criteria

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
  • Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
  • Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

  • Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
  • History of clinically-significant illness or any other major medical disorder that may interfere with the 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): NCT02292706


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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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02292706    
Other Study ID Numbers: GS-US-337-1431
2014-001249-26 ( EudraCT Number )
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gileadclinicaltrials.com/transparency-policy/
Keywords provided by Gilead Sciences:
HCV Cirrhosis registry
Cirrhosis
Hepatitis C
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Cirrhosis
Fibrosis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Hepatitis, Chronic
Chronic Disease
Sofosbuvir
Antiviral Agents
Anti-Infective Agents