(duplicate) MK7009 + Peg-INF & RBV in Treatment Naive Hep C Infected P

• Research type

  Research Study

• Full title

  A Phase II, Randomised, Placebo-Controlled Study to Evaluate the Safety, Tolerability & Efficacy of Different regimens of MK7009 When Administered Concomitantly With pegylated Interferon & Ribavirin in treatment Naive Patients With chronic Genotype 1 Hepatitis C Virus Infection

• IRAS ID

  33483

• Sponsor organisation

  Merck Sharp & Dohme Ltd

• Eudract number

  2009-012000-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Hepatitis C is a virus that can seriously damage the liver and affect its ability to function correctly. It is mainly spread through contact with the blood (or less commonly other bodfluds) of a person who is infected. 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. The current standard drug treatment (a combination of pegylated interferon and ribavirin) is effective in only about 50% of cases of infection with hepatitis C genotype 1 (the most common genotype in the UK), and there is a need for new medicines to increase the effectiveness of hepatitis C treatment. MK7009 is an experimental drug that may be useful in the treatment of hepatitis C. In this study it will be used in combination with the current standard treatment to see if by adding MK7009 to the current treatment we can increase the effectiveness of treatment as measured by the clearance of the Hepatitis C virus from the body. The study will take place at the Royal Free Hospital, London and is being sponsored by the company that makes MK7009.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/39

• Date of REC Opinion

  15 Oct 2009

• REC opinion

  Further Information Favourable Opinion