Common Variable Immunodeficiency

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

NCT00542997 | PHASE 3 | INTERVENTIONAL

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

19 Sites

51 Participants

Recruiting

2 Years to 65 Years

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Find closest sites:

SUBMIT

Study site

Paris,France,75743

Study site

Berlin,Germany,13353

Study site

Düsseldorf,Germany,40001

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Freiburg,Germany,79095

Study site

Hannover,Germany,30625

Study site

Leipzig,Germany,04129

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Mainz,Germany,55131

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Munich,Germany,80337

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Brescia,Italy,25123

Study site

Warsaw,Poland,04-736

Study site

Bucharest,Romania,020393

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Cluj-Napoca,Romania,400162

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Timisoara,Romania,300011

Study site

Barcelona,Spain,08036

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Sevilla,Spain,41013

Study site

Göteborg,Sweden,41685

Study site

Berne,Switzerland,3010

Study site

Cardiff,United Kingdom,CF144XW

Study site

London,United Kingdom,NW32QG

Study Eligibility Criteria

Inclusion Criteria

* Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
* Chest X-ray or CT scan obtained within 1 year prior to enrolment

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
* Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
Additional criteria may apply and examination by an investigator is required to determine eligibility.

Additional Studies

Additional studies can be found at ClinicalTrials.gov