Gammaplex ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
63特発性血小板減少性紫斑病2
65原発性免疫不全症候群6

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00504075
(ClinicalTrials.gov)
September 200718/7/2007A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic PurpuraChronic Idiopathic Thrombocytopenic PurpuraBiological: Gammaplex, intravenous immunoglobulinBio Products LaboratoryNULLCompleted18 Years70 YearsAll35Phase 3United States;Argentina;India
2EUCTR2011-005586-21-Outside-EU/EEA
(EUCTR)
07/12/2011A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic PurpuraA Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a Idiopathic thrombocytopenic purpura.
MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Bio Products Laboratory LimitedNULLNAFemale: yes
Male: yes
35Phase 3Argentina;India;United States

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
1EUCTR2013-002290-21-HU
(EUCTR)
13/10/201414/07/2014Study to compare the blood levels and safety of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency DiseasesA Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases - Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency Primary immunodeficiency diseases
MedDRA version: 17.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
INN or Proposed INN: Human Normal Immunoglobulin
Product Name: Gammaplex 10
INN or Proposed INN: Human Normal Immunoglobulin
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
48Phase 3United States;Hungary;United Kingdom
2EUCTR2013-002290-21-GB
(EUCTR)
30/04/201421/10/2013Study to compare the blood levels and safety of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency DiseasesA Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases - Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency Primary immunodeficiency diseases
MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
INN or Proposed INN: Human Normal Immunoglobulin
Product Name: Gammaplex 10
INN or Proposed INN: Human Normal Immunoglobulin
Bio Products Laboratory LimitedNULLNot RecruitingFemale: yes
Male: yes
48Phase 3United States;Hungary;Israel;United Kingdom
3NCT01963143
(ClinicalTrials.gov)
February 201413/9/2013Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency DiseasesA Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency DiseasesPrimary Immune Deficiency Disorders;Common Variable Immunodeficiency;X-linked Agammaglobulinaemia;Hyper-IgM SyndromeBiological: Gammaplex (5%);Biological: Gammaplex 10Bio Products LaboratoryNULLCompleted2 Years55 YearsAll48Phase 3United States;Hungary;United Kingdom
4NCT01289847
(ClinicalTrials.gov)
March 201127/1/2011A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary ImmunodeficiencyA Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and AdolescentsPrimary Immune Deficiency Disorders;Common Variable Immunodeficiency;X-linked Agammaglobulinemia;Hyper-IgM Syndrome;Wiskott-Aldrich SyndromeBiological: GammaplexBio Products LaboratoryNULLCompleted2 Years16 YearsAll25Phase 4United States;Chile;Israel
5NCT00278954
(ClinicalTrials.gov)
January 200618/1/2006Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.A Phase III, Multicenter, Open-Label Study To Evaluate The Efficacy, Safety, and Pharmacokinetics of Gammaplex® in Primary Immunodeficiency DiseasesPrimary Immunodeficiency;Common Variable Hypogammaglobulinemia;X-linked Hypogammaglobulinemia;Hypogammaglobulinemia;Immunodeficiency With Hyper-IgM;Wiskott-Aldrich SyndromeBiological: Gammaplex (Intravenous immunoglobulin)Bio Products LaboratoryNULLCompleted3 YearsN/AAll50Phase 3United States
6EUCTR2011-005679-18-Outside-EU/EEA
(EUCTR)
07/12/2011A research study to determine if Gammaplex®, is safe, tolerable, and effective when given to children and adolescents who have Primary Immunodeficiency Diseases (PID)A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents - n/a Primary immunodeficiency diseases
MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Bio Products Laboratory LimitedNULLNAFemale: yes
Male: yes
25Phase 4Chile;United States