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Clinical Trials/EUCTR2013-000961-36-DE
EUCTR2013-000961-36-DEActive, not recruitingPhase 1

Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed

Kedrion SpA0 sites35 target enrollmentStarted: August 5, 2013Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
35
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •Inclusion criteria for ITP patients:
  • •1. Patients with a diagnosis of persistent ITP (3 to 12 months from diagnosis) or chronic ITP (lasting for more than 12 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.
  • •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

  • •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. Kidney disorders characterised by proteinuria = 3.5 g/24hr, 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 the Cockroft formula.
  • •7. 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.
  • •8. Patients unable to give Informed consent by themselves will be excluded (only for Germany)
  • •9. 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 for ID patients:
  • •1. Acute bacterial infections requiring treatment with intravenous antibiotics within 1 week from enrolment
  • •2. 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)
  • •3. Positivity for thrombophilia test (homocysteine test, ATIII, Protein C and S, FV Leiden - screening test, Fibrinogen)
  • •Exclusion criteria (ITP Patients):
  • •1. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension.
  • •2. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 month.

Investigators

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