M11-646 Sapphire I:DAAs for treatment naive adults with chronic Hep C

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT 450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)

• IRAS ID

  115469

• Contact name

  Stephen David Ryder

• Sponsor organisation

  Abbott

• Eudract number

  2012-002019-25

• Research summary

  Hepatitis C viral (HCV) infection is the most common chronic liver disease worldwide with an estimated 170 million people infected. HCV predominantly affects liver cells, which causes the liver to become inflamed and damaged. If the disease progresses it can result in damage to the digestive system, the immune system (how your body fights off illnesses) and the brain. Current treatment options available have improved in recent years, however these treatments can cause significant side effects, resulting in patients stopping their treatment before they have been cured of the virus. As such there is still a clear need to develop treatments for hepatitis C that can be better tolerated. Drug companies are developing drugs which act directly on the virus. These drugs called ??Direct-Acting Antiviral Agents?? (DAAs) work by targeting the different stages of the virus lifecycle. Abbott has three DAAs in development (ABT-450/r, ABT-267 and ABT-333). This study will test the drugs to check that they are safe and able to reduce the amount of hepatitis C virus in the blood. DAAs could lead to reduced treatment times for patients and/or improve the response of the patient to the treatments when given in combination together. DAAs may be better tolerated thus improving the overall outcome for the patient. Patients that have been infected with HCV for at least 6 months and have never received medication to treat their infection could be eligible to take part in this study. The study will be conducted in clinics in the UK. Subjects will attend regular study visits at clinics over a 77 week period. The effect of the treatment on the virus will be checked by performing blood tests and collecting general medical health information.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1986

• Date of REC Opinion

  19 Dec 2012

• REC opinion

  Favourable Opinion