Gammanorm ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
14Chronic inflammatory demyelinating polyneuropathy1
65Primary immunodeficiency4

14. Chronic inflammatory demyelinating polyneuropathy


Clinical trials : 167 Drugs : 158 - (DrugBank : 38) / Drug target genes : 13 - Drug target pathways : 23
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. Primary immunodeficiency


Clinical trials : 482 Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02503293
(ClinicalTrials.gov)
July 29, 20151/7/2015A 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 PushA 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 PushPrimary ImmunodeficiencyDevice: Chrono Super PID then Generic Syringe-Gammanorm;Device: Generic Syringe then Chrono Super PID-GammanormOctapharmaNULLCompleted18 YearsN/AAll30Phase 4Australia;Germany;Italy;United Kingdom
2EUCTR2014-003746-27-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
3EUCTR2014-003746-27-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
4NCT02180763
(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