Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this research trial is to find out whether NOV-205 is well tolerated compared
to placebo (salt water) in people with hepatitis C. In addition, this trial will test how
NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it
will look for early signs of therapeutic activity (decreases in indicators in the blood for
the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205
is an experimental drug. "Experimental" means that the trial drug is currently being tested
and is not approved for sale in the United States by the Food and Drug Administration (FDA).
However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases
including hepatitis C. Clinical studies in that country showed that subjects treated with
NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver
damage.