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Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Inclusion criteria for ID patients:
1. Patients with a diagnosis of primary or secondary hypo-gammaglobulinaemia or a-gammaglobulinaemia.
2. Males or females aged between 18 and 64 years (= 18 and = 64 years).
3. Patients in treatment with intravenous immunoglobulins for at least 6 months prior to study entry.
4. Written informed consent and consent to handle personal data by participating subjects or legal guardians.
Inclusion criteria for ITP patients:
1. Patients with a diagnosis of persistent ITP (3 to 12 months from diagnosis), chronic ITP (lasting for more than 12 months) and new diagnosis of ITP (from diagnosis to 3 months).
2. Males or females aged between 18 and 64 years (= 18 and = 64 years).
3. Patients who have made at least one previous treatment with immunoglobulin.
4. Baseline platelet count: <20x109/l
5. Written informed consent and consent to handle personal data by participating subjects or legal guardians.
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 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria (ID Patient):
1. Patients who have not previously had therapy with immunoglobulins.
2. Positivity for HIV, HCV, HBV, risky behaviour for blood-transmitted viral infections such as drug abuse or risky sexual relations
3. Pregnant or breastfeeding women or women of childbearing age who do not use an adequate system of contraception.
4. Severe systemic conditions or associated conditions contraindicating the use of immunoglobulins such as severe thrombocytopenia, clotting disorders, known deficiency of one or more IgG subclasses, IgA deficit or presence of IgA antibodies, allergic reactions to immunoglobulins or the presence of a history of severe adverse reactions to blood or blood products.
5. Acute bacterial infections requiring treatment with intravenous antibiotics within 1 week from inclusion in the study
6. Kidney disorders characterised by proteinuria = 3.5 g/24hr, serum protein levels < 60 g/l or serum albumin levels < 30 g/l.
7. Chronic kidney disease or creatinine clearance < 80 ml/min in accordance with the Cockroft formula.
8. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension, lymphoma, hypoalbuminaemia, protein-losing enteropathy (characterised levels of serum protein < 60 g/l and serum albumin < 30 g/l).
9. Positivity for thrombophilia test (homocysteine test).
10. Subjects will be excluded from the study in the presence of any condition that in the Investigator’s opinion may interfere with the evaluation of study results.
11. Subjects who had participated in a clinical trial with another product within one month (30 days) from enrolment or subjects who do not wish to give their consent to participate will be excluded from the study
Exclusion criteria (ITP Patients):
1. Patients who have not previously had therapy with immunoglobulins.
2. Positivity for HIV, HCV, HBV, risky behaviour for blood-transmitted viral infections such as drug abuse or risky sexual relations
3. Pregnant or breastfeeding women or women of childbearing age who do not use an adequate system of contraception.
4. Severe systemic conditions or associated conditions contraindicating the use of immunoglobulins, , known deficiency of one or more IgG subclasses, IgA deficit or presence of IgA antibodies, allergic reactions to immunoglobulins or hypersensitivity to any of the excipients, the presence of a history of severe adverse reactions to blood or blood products.
5. Kidney disorders characterized by proteinuria = 3,5 g/24 hr, serum protein levels < 60 g/l or serum albumin levels < 30 g/l.
6. Chronic kidney disease or creatinine clearance < 80 ml/min, in accordance with Cockroft formula.
7. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension.
8. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 month.
9. Subjects will be excluded from the study in the presence of any condition that in the Investigator’s opinion may interfere with the evaluation of study results.
10. Subjects who had participated in a clinical trial with another product within one month (30 days) from enrolment or subjects who do not wish to give their consent to participate will be excluded from the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of tolerability and safety of Ig VENA administered at high infusion rates;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of tolerability and safety of Ig VENA administered at high infusion rates;Timepoint(s) of evaluation of this end point: For all the study period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable

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