COMBINED THERAPY WITH PEG-INTERFERON-a, RIBAVIRIN AND RITUXIMAB OF HEPATITIS C VIRUS-RELATED MIXED CRYOGLOBULINEMIA - ND
- Conditions
- MedDRA version: 9.1Level: SOCClassification code 10005329patients anti-HCV, HCV RNA positivity, Na?ve, with cryoglobulinemic vasculitis (detection of serum cryoglobulins associated with purpura, arthralgias and weakness)and with chronic hepatitis
- Registration Number
- EUCTR2010-020659-30-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to avoid the enhanced viral load and to evaluate the disappearance of B cell clonalities from the blood (molecular response).;Secondary Objective: to avoid the enhanced viral load and to evaluate the disappearance of B cell clonalities from the blood (molecular response).;Primary end point(s): the objective response rate, namely the proportion of patients who achieve a complete response at any time. Complete response will be based on disappearance of cryoglobulins (immunological response), undetectability of serum HCV RNA (virologic response) and disappearance of B cell clonalities from the blood (molecular response).
- Secondary Outcome Measures
Name Time Method