Vivaglobin ( DrugBank: - )


2 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4
65原発性免疫不全症候群8

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


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-000710-37-GB
(EUCTR)
10/04/200815/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;Italy;United Kingdom
2EUCTR2007-000710-37-DE
(EUCTR)
10/12/200710/09/2007A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
3NCT00701662
(ClinicalTrials.gov)
November 200718/6/2008A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)Multifocal Motor Neuropathy (MMN)Biological: VivaglobinCSL BehringNULLCompleted18 YearsN/AAll8Phase 2Italy;Switzerland;United Kingdom;Germany
4EUCTR2007-000710-37-IT
(EUCTR)
04/10/200712/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - NDA multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.
MedDRA version: 9.1;Level: LLT;Classification code 10036105;Term: Polyneuropathy
Trade Name: Vivaglobin
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01354587
(ClinicalTrials.gov)
October 201018/3/2011Evaluation of Efficacy and Tolerability of Hizentra®Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)Primary Immunodeficiency DisordersDrug: HizentraUniversity of South FloridaNULLRecruiting1 Year75 YearsBoth50N/AUnited States
2EUCTR2006-006522-25-GR
(EUCTR)
08/01/200804/06/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 4Greece;Spain;Belgium;Germany;Italy;United Kingdom
3EUCTR2006-006522-25-GB
(EUCTR)
10/09/200728/03/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Spain;Belgium;Germany;Italy;United Kingdom
4EUCTR2006-006522-25-IT
(EUCTR)
13/08/200731/07/2007A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - NDA Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.
MedDRA version: 6.1;Level: PT;Classification code 10057863
Trade Name: Vivaglobin
INN or Proposed INN: immunglobulin (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece
5EUCTR2006-006522-25-ES
(EUCTR)
01/07/200703/03/2010Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID))Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)) Pacientes con inmunodeficiencia primaria como inmunodeficiencia variable común (CVID) o agammaglobulinemia vinculada al cromosoma X (XLA) de entre 1 y 70 años de edad.(Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years)
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 4Greece;Belgium;Spain;Germany;Italy;United Kingdom
6EUCTR2006-006522-25-BE
(EUCTR)
27/06/200717/04/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece
7NCT00520494
(ClinicalTrials.gov)
March 200723/8/2007Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary ImmunodeficiencyA Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)Common Variable Immunodeficiency;AgammaglobulinemiaDrug: VivaglobinCSL BehringNULLCompleted1 Year70 YearsAll18Phase 4Canada;Germany;Italy;Spain;Belgium
8EUCTR2006-006522-25-DE
(EUCTR)
01/02/200707/12/2006A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece