EUCTR2006-002483-26-IT
Active, not recruiting
Not Applicable
Tailoring antiviral therapy of chronic hepatitis C to the single patient standard therapy versus treatment guided by a physic-mathematical model of the dynamics of Hepatitis C Virus infection. - Tailoring antiviral therapy by HCV dynamics
AZIENDA OSPEDALIERA PISANA0 sites240 target enrollmentMarch 23, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C with or without cirrhosis
- Sponsor
- AZIENDA OSPEDALIERA PISANA
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic hepatitis C with or without cirrhosis and are either therapy na ve or were relapsers after a previous standard therapy course. Their age will range between 18 and 70 years and females have to be willing to be able to take preventive contraceptive measures during treatment and for 6 months after the end of therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Pregnant or breast feeding women; Chronic liver disease with signs of portal hypertension oesophageal or gastric varices at endoscopy and or history of episodes of liver decompensation; Hepatocellular carcinoma; Subjects with organ transplant, except corneal and hair transplants; Known or suspected toxicity from standard Interferons, PEG\-Interferons or ribavirin; Treatment with any other experimental drugs within 30 days since the recruitment date; Subjects with any form of haemoglobin disease, not only major and minor talaxemia; Positive HIV sierology
Outcomes
Primary Outcomes
Not specified
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