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GS-US-342-1143 A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

NCT03022981

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Associated Conditions

Infectious Disease

Principal Investigator

Sponsor

Gilead Sciences

Hepatitis C is a disease caused by a virus (known as HCV). A virus is a very small organism that attaches itself to healthy cells and forces them to make more of the virus. The body tries to fight viruses, but the hepatitis C virus is very strong. In some people, the virus will change to fight back against the body's defenses. It may also change and become resistant to the drugs given to treat the virus (this is known as 'resistance'). The hepatitis C virus (HCV) lives in the liver. When it invades healthy liver cells, it causes those cells to become inflamed. Over time, this may cause scarring (fibrosis) of the liver or permanent liver damage (cirrhosis) which will affect the way that the liver functions. In addition, people infected with chronic HCV may develop liver cancer and/or need a liver transplant. There are 6 different subtypes of HCV called genotypes (GT). The purpose of this study is to see if giving Sofosbuvir/Velpatasvir for 12 weeks to children and teenagers with HCV infection is safe and can treat their HCV.

This study is currently enrolling.