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Clinical Trials/EUCTR2013-000620-34-DE
EUCTR2013-000620-34-DEActive, not recruitingNot Applicable

A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes

FB Biotechnologies0 sites55 target enrollmentStarted: August 5, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
55
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

  • •- Male or female aged from 2 to 70 years old
  • •- Primary immunodeficiency syndrome with predominant antibody deficiency as: X-linked agammaglobulinaemia (XLA), Common variable immunodeficiency (CVID), Other PID syndrome in which the main immunological defect is deficiency in IgG production.
  • •- Stable IgG therapy for at least 5 months before the study, with a constant dose ranging from 0.2 to 0.8 g/kg per month and with regular intervals of 3 to 4 weeks for IVIg and one week for SCIg.
  • •- At least 2 documented serum IgG trough levels = 5 g/l with the previous IgG dosage regimen.
  • •- For women of childbearing potential, negative blood pregnancy test at enrolment and agreement to use a medically-acceptable method of contraception throughout the study.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 25
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 25
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

  • •- History of severe allergy or serious adverse reaction to any IVIg, SCIg or an excipient of LFB-IgSC.
  • •- Patient with known antibodies to IgA.
  • •- Glomerular filtration rate < 80 ml/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) calculation.
  • •- Progressive hepatic disease that could worsen during the study.
  • •- Refusal of PK study (for adults only).
  • •- History of cardiac ischemia, cardiac insufficiency, cerebral ischemia, stroke, thrombotic events or pulmonary embolism.
  • •- Any additional cause of immunodeficiency, other than a primary immunodeficiency, (such as acquired immunodeficiency or malignancy of lymphoid cells).
  • •- Allogenic haematopoietic stem cell transplantation.
  • •- Need for routine premedication before SCIg infusions (excluding dermal anaesthetics).
  • •- Need for long-term therapy with corticosteroids or prophylactic antibiotics during the study.
  • •- Immunosuppressive agents, including anti-CD20 antibodies, during the last 6 months.

Investigators

Sponsor
FB Biotechnologies

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