|Responsible Party:||National Institutes of Health Clinical Center (CC) National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov 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):
Directly Acting Antiviral
Link - http://clinicaltrials.gov/ct2/show/NCT01805882?term=hepatitis+c&cond=%22Hepatitis+C+Virus%22&lup_s=02%2F04%2F2013&lup_d=30
|Hepatitis C, Chronic||Drug: Fixed Dose GS-7977/GS-5885|
Drug: GS-7977 + GS-9669
- 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.
|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|
Clinical Trial Updates