See the full title

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-000961-36-DE
• Date of registration: 05/08/2013
• Prospective Registration: Yes
• Primary sponsor: Kedrion SpA
• Public title: See the full title
• Scientific title: Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed
• Date of first enrolment: 15/11/2013
• Target sample size: 35
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000961-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Italy

Contacts

• Name: Manuela Scarpellini
• Affiliation: Kedrion SpA

• Name: Manuela Scarpellini
• Affiliation: Kedrion SpA

Key inclusion & exclusion criteria

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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
MedDRA version: 16.1 Level: PT Classification code 10054979 Term: Secondary immunodeficiency System Organ Class: 10021428 - Immune system disorders
MedDRA version: 16.1 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set
Ig VENA 50 g/l solution for infusion 200 ml vial + infusion set
Pharmaceutical Form: Solution for infusion

Primary Outcome(s)

Secondary Objective: Not Applicable

Main Objective: The objective is to verify that the IMP can be administered at higher infusion speed than that currently reported in the SmPC in some patients already treated with IVIG with a good tolerability record, by progressively increasing the infusion rate during treatment cycles, up to a defined value of 8 ml/kg/h.

The study is not intended to extend this way of administration to the whole patient population treated with the product.

Timepoint(s) of evaluation of this end point: For all the study period

Primary end point(s): Evaluation of tolerability and safety of Ig VENA administered at high infusion rates

Secondary Outcome(s)

Secondary end point(s): Not Applicable

Timepoint(s) of evaluation of this end point: Not Applicable

Secondary ID(s)

KB057

Source(s) of Monetary Support

Kedrion SpA