Wednesday, March 6, 2013

Recruiting Phase 2 Trial: Sofosbuvir(GS-7977) Interferon Sparing

Responsible Party:National Institutes of Health Clinical Center (CC) National Institute of Allergy and Infectious Diseases (NIAID) Identifier:NCT01805882 History of Changes
Other Study ID Numbers:130066, 13-I-0066
Study First Received:March 5, 2013
Last Updated:March 5, 2013
Health Authority:United States: Federal Government

Verified December 2012 by National Institutes of Health Clinical Center (CC)

Keywords provided by National Institutes of Health Clinical Center (CC):

Interferon Sparing
Directly Acting Antiviral
Ribavarin Sparing

This study is currently recruiting participants.
Hepatitis C, ChronicDrug: Fixed Dose GS-7977/GS-5885
Drug: GS-7977 + GS-9669
Phase 2

- GS-7977, GS-5885, and GS-9669 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885 and CS-9669 may also lower the amount of HCV in the body. Researchers want to see whether GS-7977 can be combined with either of the other two drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977 and GS-9669.
- To see whether GS-7977 with GS-5885 or GS-9669 can be used to treat HCV infection.
  • Individuals at least 18 years of age who have chronic HCV infection and have never been treated for it.
  • Individuals at least 18 years of age who have chronic HCV infection and have not responded to interferon therapy.
  • Participants will be screened with a physical exam and medical history. Blood samples will be collected. A liver biopsy may also be performed.
  • Participants will take the two study drugs. Those who take GS-7977 and GS-5885 will have one daily tablet. Those who take GS-7977 and CS-9669 will have three daily tablets.
  • Treatment will be monitored with frequent blood tests. These tests will check liver function and the level of HCV infection. Participants may have other blood tests as needed for treatment.
  • Participants will have 12 weeks of treatment. After 12 weeks, they will stop treatment with the study drugs. They may also have another liver biopsy.
  • Participants will have regular follow-up visits over the next 48 weeks. They will have physical exams and provide blood samples.

Arms Assigned Interventions
Experimental: GS-7977/GS-5885 in treatment naive patients
GS-7977/GS-5885 for 12 weeks
Drug: Fixed Dose GS-7977/GS-5885
Experimental: GS-7977 + GS-9669 in treatment naive patients
GS-7977 + GS-9669 for 12 weeks
Drug: GS-7977 + GS-9669

Detailed Description:
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. While treatment with ribavirin (RBV) and pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV alone in HCV monoinfected patients, treatment is still associated with a high incidence of adverse events (AEs), discontinuations, and poor cure rates in several populations. Recent studies have demonstrated that the use of a combination of antivirals which target HCV without interferon (IFN) can cure HCV without additional toxicities. However, the determinants of response to IFN-free regimens has not been established and early studies suggest a differential treatment response between IFN treatment na ve subjects and null responders to previous IFN-based therapy.
This is an open label study to assess the safety, tolerability, and efficacy of GS-7977 in combination with either GS-5885 or GS-9669 (selective HCV nucleotide NS5B, and NS5A and nonnucleotide NS5B inhibitors, respectively) in HCV monoinfected treatment na ve and treatment experienced subjects. The findings from this study will aid in our understanding of determinants of response to an IFN-free regimen in HCV monoinfected patients.

Clinical Trial Updates

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