Gammanorm ( 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1
65原発性免疫不全症候群3

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
1EUCTR2017-002024-24-DK
(EUCTR)
08/09/201719/06/2017Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathyRandomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gammanorm
Product Name: Gammanorm
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus Unversity HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Denmark

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
1EUCTR2014-003746-27-GB
(EUCTR)
16/04/201514/01/2015A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using an infusion pump or syringeA randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push - Gammanorm in immunodeficient patients: quality of life using infusion by pump or rapid push immunodeficiency syndrome
MedDRA version: 19.0;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Gammanorm 165 mg/mLOctapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, AustriaNULLNot RecruitingFemale: yes
Male: yes
40Phase 3;Phase 4Australia;Germany;United Kingdom
2EUCTR2014-003746-27-DE
(EUCTR)
15/04/201501/12/2014A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using an infusion pump or syringeA randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push - Gammanorm in immunodeficient patients: quality of life using infusion by pump or rapid push immunodeficiency syndrome
MedDRA version: 19.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Gammanorm 165 mg/mLOctapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, AustriaNULLNot RecruitingFemale: yes
Male: yes
40Phase 3;Phase 4Australia;Germany;Italy;United Kingdom
3NCT02180763
(ClinicalTrials.gov)
April 201423/6/2014Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or PumpsA Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.Primary Immunodeficiency (PID)Biological: GammanormOctapharmaNULLCompleted18 YearsN/AAll31Phase 4France