Chronic Hepatitis C
Conditions
Interventions
Trade Name: Plavix®
Product Name: Plavix®
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Aspirin®
Product Name:
Sponsors
Medizinische Universität Wien; Univ.Klin.f.Innere Med. III, Abt.f.Gastroenterologie u. Hepatologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Cirrhosis: CHILD-PUGH Stage B and C -Impaired haemostasis (PTZ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether inhibition of platelet activation by either ASS+ Clopidogrel + Cilostazol or by Dabigatran etexilate significantly lowers plasma transaminase levels (ALAT) in comparison to placebo.;Secondary Objective: 1)-To measure plasma levels of the pro-inflammatory chemokines RANTES and MIP1a before and after platelet inhibition. 2)-To measure plasma levels of P-selectin before and after thrombocyte inhibition. 3)-To investigate whether the percentage of P-selectin, GPIIa/IIIb, thrombin receptor positive platelets is lower after than before thrombocyte inhibition. 4)-To measure plasma levels of vWF before and after thrombocyte inhibition. 5)-To observe effects of ASS + Clopidogrel + Cilostazol and Dabigatran etexilate on EPI and ADP-CT as measured by PFA-100. 6)-To observe possible effects of inhibition of platelet activation on platelet count 7)-To observe effects of thrombocyte inhibition on thrombelastography (TEG). 8)-To observe the level of anti-platelet antibody. ;Primary end point(s): Level of ALAT after 1 month of treatment with anti-platelet medication | — |
Countries
Austria
Outcome results
None listed