Impact of Inhibition of Thrombocyte Activation on the course of chronic Hepatitis C

• Conditions: Chronic Hepatitis C

• Registration Number: EUCTR2008-002060-34-AT
• Lead Sponsor: Medizinische Universität Wien; Univ.Klin.f.Innere Med. III, Abt.f.Gastroenterologie u. Hepatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- confirmed chronic hepatitis C (IFN-naive or non-responders/relapsers to previous therapy)

-ALAT (GPT) > 80 U/l for women, and > 90 U/l for men. These values represent double the upper limit of the normal range of ALAT, which is different for males and females.

-Age: 19 years or older

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Cirrhosis: CHILD-PUGH Stage B and C

-Impaired haemostasis (PTZ < 50)

-Impaired kidney function (Creatinine > 1.3mg/dl)

-Co-infection with HBV or HIV

-Platelet count < 50,000/µl

- History of variceal bleeding or evidence of GI blood loss

- History of thromboembolic or severe cardiovascular disease

-Hypertension not responding to anti-hypertensive treatment

-History of convulsion

-Participation in a clinical trial in the 3 weeks preceding the study

-IFN-therapy within 6 months of inclusion into the study.

-Use of anti-thrombotic or anticoagualant medication.

-Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified