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Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

Expanded access is currently available for this treatment.
Verified January 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01779518
First received: January 23, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.


Condition Intervention
Post-transplant Recurrent Hepatitis C
 Drug: Sofosbuvir + RIbavirin +/- Pegylated Interferon

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Intervention Details:
    Drug: Sofosbuvir + RIbavirin +/- Pegylated Interferon
    Other Name: Sofosbuvir is also known as GS-7977 or PSI-7977.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Age > or = 18 years
  • Previously undergone orthotopic liver transplant (OLT)
  • Aggressive recurrent Hepatitis C infection (including fibrosing cholestatic hepatitis C)
  • Life expectancy of < 18 months if the HCV is left untreated

Exclusion Criteria:

  • Unlikely to benefit from treatment for their HCV infection due to the severity of hepatic disease or their overall poor medical condition
  • Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject safety, treatment, assessment, or compliance
  • Evidence of hepatocellular carcinoma (HCC)
  • Specific signs of decompensated liver disease as assessed by the study doctor based on medical history, laboratory tests and physical exam
  • Unable or unwilling to follow the contraception requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779518

Contacts
Contact: PPD, Inc. PPD, Inc 7977access@ppdi.com

Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01779518     History of Changes
Other Study ID Numbers: GS-US-334-0139
Study First Received: January 23, 2013
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Gilead Sciences:
HCV
Sustained Virologic Response
Direct Acting Antiviral
GS-7977
Pegylated interferon
Ribavirin
Open Label
Sofosbuvir
Liver transplant
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Anti-Infective Agents
Interferons
Ribavirin
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antiviral Agents
Antimetabolites

ClinicalTrials.gov processed this record on May 19, 2013