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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:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
55

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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