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Clinical Trials/EUCTR2006-006745-13-PL
EUCTR2006-006745-13-PLActive, not recruitingPhase 1

A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID)

CSL Behring0 sites51 target enrollmentStarted: August 11, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
51
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 > 24 months and £ 65 years
  • •· Subjects with primary humoral immunodeficiency, namely with a
  • •diagnosis of
  • •o CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies)
  • •o or XLA as defined by PAGID and ESID
  • •o or Autosomal Recessive Agammaglobulinemia
  • •· Subjects who have received
  • •o IVIG therapy at regular 3- or 4-week intervals
  • •o or SCIG therapy at regular weekly intervals at a stable dose (variations of ± 10% are allowed) for at least 6 months prior to receiving IgPro20 (maintenance dose to reach a
  • •cumulative monthly dose of the order of 0.2 – 0.8 g/kg)
  • •· At least 3 documented IgG trough levels of = 5 g/L during 3 months on IVIG or SCIG replacement therapy immediately prior to receiving IgPro20; 2 of the 3 IgG trough levels may go back up to 6 months prior to receiving IgPro20, in case of stable dosing
  • •for at least 3 months prior to this assessment
  • •· Chest X-ray or CT Scan obtained within 1 year prior to
  • •· Women of childbearing potential using medically approved contraception and having a negative pregnancy test at screening
  • •· Written informed consent
  • •Inclusion criteria for PK assessment
  • •· Male or female aged = 6 years
  • •· Written informed consent
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •· Newly diagnosed PID, i.e. subjects who have not previously
  • •received immunoglobulin replacement therapy
  • •· Ongoing serious bacterial infection at the time of screening
  • •· Malignancies of lymphoid cells such as lymphocytic leukemia,
  • •Non-Hodgkin’s lymphoma and immunodeficiency with thymoma
  • •· Known hyperprolinemia
  • •· Hypoalbuminemia, protein- losing enteropathies, and any
  • •proteinuria (defined by total urine protein concentration > 0.2
  • •· Allergic or other severe reactions to immunoglobulins or other
  • •blood products associated with high anti-IgA
  • •· The subject is receiving steroids (oral and parenteral, daily = 0.15
  • •mg of prednisone equivalent/kg/day) or other systemic
  • •immunosuppressants
  • •· Females who are pregnant, breast feeding or planning a
  • •pregnancy during the course of the study
  • •· A positive result at screening on any of the following viral
  • •markers: HIV, HCV or HBV
  • •· ASAT or ALAT concentration > 2.5 times Upper Limit of
  • •Normal Range (ULNR)
  • •· Creatinine concentration > 1.5 times ULNR
  • •· Participation in a study with an investigational product other than
  • •immunoglobulin within 3 months prior to enrollment
  • •· Evidence of uncooperative attitude
  • •· Any condition that is likely to interfere with evaluation of the
  • •study drug or satisfactory conduct of the trial
  • •· Patients who are employees at the investigational site, relatives or
  • •spouse of the investigator

Investigators

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