Study of GS-7977 with Ribavirin in patients with HCV infection

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Treatment Naïve and Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection

• IRAS ID

  109017

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2012-001942-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Study to evaluate the Efficacy and Safety of GS-7977 Ribavirin for 12 Weeks in Treatment NaÇîve and Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection. GS-7977 is a new medication that is experimental. Experimental means that it has not been approved by the relevant authorities in the UK and in other countries. Experimental medications may be tested in research studies such as this one. Hepatitis C is a disease caused by a virus (known as HCV) which infects liver. A virus is a very small organism that attaches itself to healthy cells and forces them to make more of the virus. The patient immune response attempts to clear the hepatitis C virus, but this is ineffective in a high proportion. Thus chronic infection results in a high proportion. Resistance may also develop when antiviral drugs are given. The Hepatitis C virus (HCV) lives in 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 liver functions. In addition, people infected with chronic HCV may develop liver cancer and/or need a liver transplant. The main purpose of the study is to help determine if GS-7977 in combination with Ribavirin for 12 weeks is safe and able to eliminate the HCV infection from your body. Approximately 400 participants will be enrolled into this study at around 80 study centres in Europe. The participants will remain in the study up to 42 weeks and will attend the following study periods: ?½Screening: up to 4-6 weeks to have their eligibility assessed ?½Study Treatment (12 weeks of taking study medication): If the participant's eligible then he/she will be assigned by chance like tossing a coin (randomisation) to one of two groups listed below. Group 1: GS-7977 400 mg and ribavirin Group 2: GS-7977 placebo and ribavirin placebo Participants will take a 400 mg pill of GS-7977 (Group 1) or GS-7977 placebo (Group 2) by mouth once a day. Ribavirin or ribavirin placebo pills will be taken by mouth and the dosage will depend on the participant's body weight. Participants will take the ribavirin or ribavirin placebo pills both in the morning and the evening as directed by the study doctor. Ribavirin and ribavirin placebo should be taken with food. Follow-Up: Upon completion of the treatment period, participants will be followed up by the study doctor and the study team for up to 24 weeks after last dose of study medication. During this period some tests will be performed to determine if the HCV has been eliminated from participant's body.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  12/NE/0266

• Date of REC Opinion

  5 Sep 2012

• REC opinion

  Further Information Favourable Opinion