I10e (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 15 |
| 63 | 特発性血小板減少性紫斑病 | 4 |
| 65 | 原発性免疫不全症候群 | 3 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-005558-31-DE (EUCTR) | 10/08/2016 | 08/07/2016 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IQYMUNE Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2013-005557-73-DE (EUCTR) | 10/08/2016 | 08/07/2016 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IQYMUNE Product Name: human normal immunoglobulin for intravenous administration Product Code: I10 INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2013-005558-31-FR (EUCTR) | 23/07/2015 | 26/06/2015 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 4 | EUCTR2012-001995-12-IT (EUCTR) | 19/05/2015 | 13/03/2013 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 15.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom;Italy | ||
| 5 | EUCTR2013-005558-31-ES (EUCTR) | 18/02/2015 | 16/12/2014 | Exstension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Human normal 10% immunoglobulin for intravenous administrationn Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2013-005558-31-IT (EUCTR) | 26/01/2015 | 20/05/2015 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: : immunoglobulina umana normale 10% per somministrazione endovenosa Product Code: I10E INN or Proposed INN: immunoglobulina umana normale per somministrazione endovenosa Other descriptive name: IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2013-005558-31-GB (EUCTR) | 08/01/2015 | 19/11/2014 | Extension of the international study on efficacy and safety of I10E in CIDP patients | International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | |||
| 8 | EUCTR2013-005557-73-ES (EUCTR) | 03/12/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | ||
| 9 | EUCTR2013-005557-73-GB (EUCTR) | 21/10/2014 | 15/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom | |||
| 10 | EUCTR2013-005557-73-IT (EUCTR) | 30/09/2014 | 27/08/2014 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 17.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 3 | France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2013-005557-73-FR (EUCTR) | 24/09/2014 | 26/06/2015 | An international study on efficacy and safety of I10E in CIDP patients | An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom | |||
| 12 | NCT01951924 (ClinicalTrials.gov) | December 2013 | 20/9/2013 | LIME Study (LFB IVIg MMN Efficacy Study) | A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy | Motor Neuron Disease | Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL) | Laboratoire français de Fractionnement et de Biotechnologies | TFS Trial Form Support | Completed | 18 Years | 80 Years | Both | 23 | Phase 3 | France;Italy;Spain;United Kingdom |
| 13 | EUCTR2012-001995-12-GB (EUCTR) | 01/08/2013 | 03/06/2013 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 18.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;Italy;United Kingdom | |||
| 14 | EUCTR2012-001995-12-ES (EUCTR) | 12/07/2013 | 12/07/2013 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.0;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom | ||
| 15 | EUCTR2012-001995-12-FR (EUCTR) | 03/07/2013 | 04/04/2014 | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy | Multifocal motor neuropathy (MMN) MedDRA version: 16.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: KIOVIG Product Name: KIOVIG INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Product Name: human normal immunoglobulin for intravenous administration Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | France;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-001354-29-ES (EUCTR) | 24/09/2012 | 19/07/2012 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy | |||
| 2 | EUCTR2011-001354-29-HU (EUCTR) | 09/11/2011 | 12/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 3 | EUCTR2011-001354-29-IT (EUCTR) | 09/11/2011 | 07/03/2012 | An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: human normal immunoglobulin for intravenous use Product Code: I10E INN or Proposed INN: NA Other descriptive name: NA | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Ukraine;Russian Federation;Germany;Italy | |||
| 4 | EUCTR2011-001354-29-DE (EUCTR) | 12/10/2011 | 06/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Other descriptive name: human Immunoglobulin | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-023483-41-FR (EUCTR) | 24/04/2013 | 04/01/2011 | A 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 BIOTECHNOLOGIES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | France;Hungary | |||
| 2 | EUCTR2010-023483-41-HU (EUCTR) | 01/03/2011 | 10/11/2010 | A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system | A 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 BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;France;Czech Republic;Hungary;Poland;Ukraine;Lithuania | |||
| 3 | EUCTR2010-023483-41-Outside-EU/EEA (EUCTR) | 11/04/2014 | A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system | 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)• 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 BIOTECHNOLOGIES | NULL | NA | Female: yes Male: yes | 60 | Poland;Serbia;Czech Republic;France;Hungary;Lithuania;Ukraine |