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Clinical Trials/EUCTR2006-002483-26-IT
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.

Registry
who.int
Start Date
March 23, 2007
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA PISANA

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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