Safety, tolerability and efficacy of GS-9450 in patients with HCV

• Research type

  Research Study

• Full title

  A Phase 2b, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS-9450 in Adults with Chronic Hepatitis C Virus Infection (GS-US-227-0106)

• IRAS ID

  17841

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2008-007456-96

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to determine if the study drug (GS-9450) is safe and suitable for patients with chronic Hepatitis C Virus (HCV) infection. HCV infection causes inflammation of the liver, a chronic infection can cause apoptosis leading to scarring of the liver (fibrosis) and advanced scarring (cirrhosis). Apoptosis, or programmed cells death is a normal function of the cells in the body and is used to maintain health and normal development. Cells die in response to a variety of situations e.g. the cell is damaged beyond repair, infected with a virus, and during apoptosis they do so in a controlled regulated fashion. When given the signal to die the cells undergo apoptosis and a number of changes occur in the cell. A family of proteins known as caspases are activated and they break down components in the cells so they can no longer live and start to die. HGS-9450 belongs to a group of drugs that block the action of caspases (inhibitor) and therefore the rate of apoptosis. The use of caspase inhibitors needs to be evaluated to see if they can improve liver health in patients with chronic HCV infection. Considering that Hepatitis C Virus is present in approximately 2% of the US population, a large number of people are at risk of liver inflammation and possibly death from the effects of this disease. This study will look at the effects of the study drug on adults with chronic Hepatitis C Virus. Approximately 240 subjects will participate in this study at up to 90 centers in the United States and Europe.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/74

• Date of REC Opinion

  24 Jul 2009

• REC opinion

  Further Information Favourable Opinion