M13-099 (Turquoise 2) DAA's for adults with chronic Hep C & Cirrhosis

• Research type

  Research Study

• Full title

  Clinical Study Protocol M13-099 A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

• IRAS ID

  114924

• Contact name

  Kaushik (Kosh) Agarwal

• Sponsor organisation

  Abbott

• Eudract number

  2012-003088-23

• Research summary

  Chronic Hepatitis C is the most common chronic liver disease worldwide with an estimated 170 million people infected with the Hepatitis C virus. The virus predominantly affects liver cells which causes the liver to become inflamed and damaged. When the liver becomes scarred and lumpy where damaged tissue regenerates, it is known as cirrhosis. 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. Treatments for this illness have improved. Current treatments can cause significant side effects, resulting in patients terminating their treatment before the virus has been eliminated. There is 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 ??Direct-Acting Antiviral Agents?? (DAAs) work by targeting the different stages of the virus lifecycle. DAAs could lead to reduced treatment times for the patient and/or improve the response of the patient to the treatments when given together and could be better tolerated thus improving the outcome for the patient. Abbott has three DAAs in development (ABT-450/r, ABT-267 and ABT-333). This study will test the drugs in combination to check that they are safe and effective for patients with Hepatitis C. Subjects who have Hepatitis C and have either never had treatment or have taken medications to treat HCV but they were not effective could be eligible to take part in this study if they also have been diagnosed to have a certain degree of cirrhosis. This diagnosis may involve the subject having a liver biopsy (where a minute piece of liver is carefully removed using a special needle, for analysis under a microscope). The study will be conducted in clinics in the UK. Subjects will attend regular study visits at clinics over a 72 week period. The effect of the treatments on the virus will be checked by performing blood tests, ultrasound scans, and collecting general medical health information.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1598

• Date of REC Opinion

  20 Dec 2012

• REC opinion

  Further Information Favourable Opinion