65. Primary immunodeficiency Clinical trials / Disease details


Clinical trials : 482 Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212

  
3 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2010-023483-41-FR
(EUCTR)
24/04/201304/01/2011A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID)A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Autosomal recessive inherited agammaglobulinemia (including autosomal recessive hyper-IgM syndrome)• Common variable immunodeficiency (CVID)• IgG subclass deficiency (at least 2 subclasses) with clinical manifestations of immunodeficiency
MedDRA version: 12.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;Hungary
2EUCTR2010-023483-41-HU
(EUCTR)
01/03/201110/11/2010A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune systemA MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) - I10E-0718 a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID)
MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870
MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
60Serbia;France;Czech Republic;Hungary;Poland;Ukraine;Lithuania
3EUCTR2010-023483-41-Outside-EU/EEA
(EUCTR)
11/04/2014A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune systemA MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID)
MedDRA version: 16.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870
MedDRA version: 16.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNAFemale: yes
Male: yes
60Poland;Serbia;Czech Republic;France;Hungary;Lithuania;Ukraine