Treatment of recently acquired hepatitis C infection study
- Conditions
- Hepatitis CInfection - Other infectious diseases
- Registration Number
- ACTRN12611000513910
- Lead Sponsor
- The University of New South Wales (acting through the Kirby Institute, formerly the National Centre in HIV Epideiology and Clinical Research))
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Male and female subjects >= 16 years of age
To have recently acquired HCV infection as defined below:
A)
i) First anti-HCV antibody or HCV RNA positive within the previous 6 months
and
ii) Documented anti-HCV antibody negative within the 24 months prior to anti-HCV antibody positive result
OR
B)
i) First anti-HCV antibody or HCV RNA positive within the previous 6 months
and
ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples, and standard exclusion criteria for pegylated interferon alfa-2a and ribavirin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of response-guided therapy strategies in recent hepatitis C (HCV) infection.[The proportion of treated subjects with SVR24 defined as undetectable HCV RNA 24 weeks post therapy.]
- Secondary Outcome Measures
Name Time Method