patients anti-HCV, HCV RNA positivity, Na?ve, with cryoglobulinemic vasculitis (detection of serum cryoglobulins associated with purpura, arthralgias and weakness)and with chronic hepatitis MedDRA version: 9.1 Level: SOC Classification code 10005329
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed