Protocol 038: MK5172 with Peg-IFN & RBV in naive HCV GT1 patients

• Research type

  Research Study

• Full title

  A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection

• IRAS ID

  113552

• Contact name

  Geoffrey Dusheiko

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2012-003333-42

• Research summary

  Hepatitis C is a leading cause of liver disease. Three quarters of infected people will develop long term infection which can lead to severe liver damage (cirrhosis), liver cancer or liver failure and the need for liver transplantation. Currently Hepatitis C treatment consists of a lengthy treatment (24 to 48 weeks) with pegylated interferon (peg-IFN) and ribavirn (RBV) and is effective in around 50% of patients. Recently, two protease inhibitors have been approved as treatment in combination with peg-IFN and RBV for hepatitis C Genotype 1 patients, which has significantly increased response rates up to ~70%. However many patients cannot tolerate the side effects of peg-IFN and lengthy duration of treatment a shorter duration of treatment would therefore be a significant advantage. The experimental drug MK5172 is a very potent protease inhibitor which has been shown to rapidly clear the HCV virus from the blood and could therefore offer an effective shorter duration treatment for HCV. A shorter duration of treatment would lead to fewer side effects suffered by patients and better treatment compliance. The MK5172-038 study is designed to look at the effectiveness and safety of different doses of MK5172 in combination with peg-IFN and ribavirin over 12 weeks and establish the best dose for future studies. Approximately 90 patients with Hepatitis C, Genotype 1, who have not previously received treatment, will be enrolled into this study. Patients will receive MK5172, with peg-IFN and RBV for a total of 12 weeks. Patients may receive an additional 12 weeks of peg-IFN and RBV alone based on their on their HCV levels after 4 weeks of treatment. The primary objective will be to evaluate the efficacy of each treatment arm determined by virus levels in the blood at 12 weeks after completing treatment. The study will take place at 3 UK NHS hospital sites and is being sponsored by the company that makes MK-5172.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0499

• Date of REC Opinion

  28 Dec 2012

• REC opinion

  Further Information Favourable Opinion