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

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Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01779518
First received: January 23, 2013
Last updated: January 15, 2014
Last verified: January 2014
  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 Hepatitis C
Drug: Sofosbuvir
Drug: Ribavirin
Drug: 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:


Further study details as provided by Gilead Sciences:

Intervention Details:
    Drug: Sofosbuvir
    Other Names:
    • GS-7977
    • PSI-7977
    • Sovaldi™
    Drug: Ribavirin Drug: Pegylated Interferon
  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) at least 2 months prior to the planned start of dosing
  • Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
  • Life expectancy of < 12 months if the HCV is left untreated

Exclusion Criteria:

  • History of clinically significant drug allergy to nucleoside/nucleotide analogs
  • Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
  • Unable or unwilling to follow the contraception requirements
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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 15, 2014
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 C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Molecular Mechanisms of Pharmacological Action
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014