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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

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ClinicalTrials.gov Identifier: NCT02292706
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This Registry will enroll cirrhotic participants 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 Type : Observational [Patient Registry]
Estimated Enrollment : 1637 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
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine



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


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


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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.


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


  Show 149 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02292706     History of Changes
Other Study ID Numbers: GS-US-337-1431
2014-001249-26 ( EudraCT Number )
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Keywords provided by Gilead Sciences:
HCV Cirrhosis registry
Cirrhosis
Hepatitis C

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Fibrosis
Liver Cirrhosis
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Interferons
Sofosbuvir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents