COMBINED THERAPY WITH PEG-INTERFERON-a, RIBAVIRIN AND RITUXIMAB OF HEPATITIS C VIRUS-RELATED MIXED CRYOGLOBULINEMIA - ND

AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE0 个研究点开始时间: 2010年9月10日最近更新: 2012年10月2日

适应症

试验速览

暂无简介。

•- Age > 18 years - anti-HCV, HCV RNA positivity - Na?ve patients (never treated before), with cryoglobulinemic vasculitis (detection of serum cryoglobulins associated with purpura, arthralgias and weakness) - Liver biopsy showing chronic hepatitis, positivity for rheumatoid factor within 3 months from enrollment - Absence of a pregnancy state - Negativity for HBsAg and anti-HIV - Capacity of the patient to participate in the proposed study and to sign an informed consent.
•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

•- Hepato-biliary malignancies - Vascular liver diseases - Child C liver cirrhosis - NYHA > 2 heart failure; acute coronary disease; arrhythmias except those treated with beta-blockers or digoxin; uncontrolled high blood pressure; ventricular arrhythmias - Acute severe infections - HBV or HIV co-infections - Psychiatric disorders - History of organ transplantation - Drug abuse - Poorly controlled diabetes mellitus - Autoimmune diseases - Alcool intake > 40 g/day during the last 6 months - Use of hepatotoxic drugs during the last 6 months - Confirmed or suspected allergies to the drugs to be used in the study - Pregnancy and breastfeeding. A pregnancy test is requested within 7 days from study enrollment. Throughout the study, a contraceptive method is strongly recommended for both sexes - Patients refusing to provide informed consent.

发起方

AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE