A Phase II Open Label Roll Over Study of MK7009+Peg-IFN & RBV (PN028)
Research type
Research Study
Full title
A Phase II Open Label Study of MK7009 Administered Concomitantly with Pegylated Interferon Alfa-2a and Ribavirin to Patients with Chronic Hepatitis C Infection After Participation in Other MK7009 Clinical Trials
IRAS ID
27013
Contact name
Paul Robinson
Contact email
Sponsor organisation
Merck Sharp & Dohme Ltd
Eudract number
2009-013053-15
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 body fluids) 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 for those patients who don’t respond to current treatment.
MK7009 is an experimental drug that may be useful in the treatment of hepatitis C.
This study will enrol patients who have previously taken part in studies of MK7009 and received treatment with pegylated interferon, ribavirin and possibly also MK7009, but did not achieve effective clearance of the hepatitis C virus. In this study all such patients will receive high dose MK7009 for a longer treatment duration than previously (48 weeks instead of 12 or 24) in combination with pegylated interferon and ribavirin to see if this treatment combination is effective in patients who have had previously unsuccessful treatment.
The study will take place at the Royal Free Hospital in London, Newcastle General Hospital and Southampton General Hospital and is being sponsored by the company that makes MK7009.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
09/H0502/92
Date of REC Opinion
2 Oct 2009
REC opinion
Further Information Favourable Opinion