Hepatitis C
2006 has been a busy year in our Clinical Research Department here at Northwest Georgia Gastroenterology. We currently have 2 new Clinical Trials enrolling for the diagnosis of Hepatitis C. Both studies are for Naïve (never had treatment for Hepatitis C) Genotype 1 patients. One study is specifically for male or female subjects over 187 pounds comparing 4 different treatment arms with Pegasys and Copegus and the other is with Peg-Intron and Rebetol and one of the newest anti-viral compounds called Protease Inhibitors. Both of these Clinical Trials will start enrolling subjects in the fall.

Hepatitis C Non-Responder Anti-Fibrotic Study
This Clinical Trial is for patients who have not responded or cleared the Hepatitis C virus and have a specific scarring or fibrosis score on their liver biopsy. This study is looking at several different doses of an investigational drug vs placebo.

Irritable Bowel Syndrome Constipation Predominant
We also have a Clinical Trial currently enrolling for patients that suffer from IBS with constipation. This study is a 12 week study investigating a new medication to help patients who suffer from constipation. It is currently enrolling and should continue enrollment into the New Year.

Crohn’s Disease
We have 2 studies enrolling for Crohn’s Disease. 1 study is for subjects that have tried Remicade and have failed or not responded to treatment. The other is for subjects that have never had treatment for this disease. Both Clinical Trials should be enrolling in the next few months.

Please feel free to Contact our Clinical Research Coordinator, Cathy Maffei, RMA,CCRC at 678-819-4237 for any information and specifics on any of these Clinical Trials.

Common list of Hepatitis C terms:

Naive

A patient who has never received treatment for their hepatitis C.

Non-responder

A patient who has undergone treatment for their hepatitis C but failed to respond or clear the virus.

Relapser

A patient who during treatment cleared the Hapatitis C virus at some point, either while still on medication or after finishing treatment was found to have Hepatitis C virus detected on their lab studies..

Hepatitis C RNA by PCR

A sensitive blood test that is done to confirm the presence of the Hepatitis C virus in a patient. This can be done either by a Qualitative test which tells us whether it is detected or non-detected, or it can be done by a Quantitative measurement, which tells how much virus is present.

Genotype

This is a test done prior to treatment that is helpful in making Recommendations and counseling regarding therapy. There are 6 known genotypes and more than 50 subtypes of Hepatitis C. When using combination therapy to treat Hepatitis C the recommended Duration of treatment depends on the genotype.

LFT’S

Liver Function Test also known as ALT and AST. This is used as a Marker of inflammation in the liver.