Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
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|ClinicalTrials.gov Identifier: NCT02468648|
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : September 21, 2018
- Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why.
- To learn why new hepatitis C drugs sometimes don t work. Also, to learn if these drugs are safe and how well they work in people with different virus strains.
- Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus.
- Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires.
- Participants will have a Fibroscan an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram.
- Eligible participants will have a liver biopsy.
- Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires.
- They will take the first study drug dose as a tablet taken once daily.
- Participants will take the drug at home for 12 weeks.
- Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires.
- At week 4, participants will have another liver biopsy.
- After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Sofosbuvir Drug: GS-5816||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816|
|Study Start Date :||June 9, 2015|
|Actual Primary Completion Date :||September 14, 2018|
|Actual Study Completion Date :||September 14, 2018|
- Drug: Sofosbuvir
An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection
- Drug: GS-5816
An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
- The primary endpoints will be changes in interferon stimulated gene and protein expression in the liver and changes in HCV RNA levels in liver and serum between baseline and 4 weeks. [ Time Frame: 4 weeks ]
- Proportion who achieve SVR12 stratified by viral genotype [ Time Frame: 12 weeks post-treat ]
- Secondary endpoints will be safety and rates of sustained virologic response 24 weeks off therapy [ Time Frame: 24 weeks post-Rx ]
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): NCT02468648
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Marc G Ghany, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|