- Are you 18 years old or older?
- Are you Hepatitis C positive?
If so, you may be eligible for this trial.
Purpose of study
Most people who are acutely infected with hepatitis C do not manage to clear the virus from their blood and will become chronic hepatitis C carriers. Chronic hepatitis C infection is defined as the persistence of hepatitis C in the liver and bloodstream after initial infection. In this case, the virus is unlikely to disappear in the future without hepatitis C treatment. Some people, maybe 20-30%, will manage to clear the virus spontaneously without any treatment, usually in the first few months after infection. The reason why some people clear the virus and others do not is not known. It is also not known at what stage the infection definitely becomes chronic or how successful treatment will be if given in the very early stages of infection.
The main purposes of the study are therefore:
- To enroll and follow-up a large group of people with acute hepatitis C infection.
- To study the number of people who manage to clear the virus spontaneously and the rate at which this occurs.
- To examine the factors that predict whether someone is able clear the virus or not.
- To look at the frequency with which re-infection or relapse occurs in people who have previously cleared the virus.
The study will also offer everyone taking part the option of undergoing a 6 month course of Pegylated –interferon as treatment for hepatitis C (see section B). The purpose of this part of the study is:
- To examine whether treatment in the acute stages of infection is effective in clearing the virus.
- To ensure that treatment in people with acute hepatitis C is safe and well tolerated.
- To examine the factors that affect whether you are likely to respond to treatment or not.
This study has been approved by St Vincent’s Hospital, Human Research Ethics Committee, Sydney, which is constituted and operates in accordance with current NHMRC guidelines.
An estimated 240 patients will be enrolled in this study throughout Australia and all patients will be followed for a 3 year period.
The study at St Vincent’s Hospital is under the direction of Dr Greg Dore.
Information on the study provided herein is extracted from the consent form approved by the relevant Ethics Board– potential participants in the study should obtain the approved consent form for their review.
PLEASE SEE ALSO CLINICAL TRIALS OVERVIEW
For more information, or a copy of the Consent Form, please email us at trials@holdsworthhouse.com.au
Or call the trials team on (02) 9331 7228
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