51. 全身性強皮症 Scleroderma Clinical trials / Disease details


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217

  
13 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
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PhaseCountries
1EUCTR2019-000906-31-DE
(EUCTR)
01/07/202031/10/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
2EUCTR2019-000906-31-GB
(EUCTR)
22/05/202029/10/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
3EUCTR2019-000906-31-BE
(EUCTR)
19/03/202009/12/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
188Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
4EUCTR2019-000906-31-IT
(EUCTR)
25/02/202022/01/2021Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis - NA efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: PRIVIGEN - 100 MG/ML - SOLUZIONE PER INFUSIONE USO ENDOVENOSO FLACONCINO(VETRO) 1 FLACONCINO DA 100 ML
Product Name: Immunoglobulina normale umana per somministrazione endovenosa
Product Code: [IgPro10]
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
5EUCTR2019-000906-31-PL
(EUCTR)
31/01/202006/12/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany
6NCT04138485
(ClinicalTrials.gov)
December 20, 201914/10/2019Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: IgPro10;Biological: PlaceboCSL BehringNULLWithdrawn18 YearsN/AAll0Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
7EUCTR2019-000906-31-ES
(EUCTR)
16/12/201920/12/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
188Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
8EUCTR2019-000906-31-FR
(EUCTR)
03/12/201908/11/2019Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
9EUCTR2018-003149-41-DE
(EUCTR)
16/07/201920/03/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
10EUCTR2018-003149-41-FR
(EUCTR)
24/05/201927/03/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Poland;Australia;Germany;Italy;United Kingdom
11EUCTR2018-003149-41-IT
(EUCTR)
23/05/201922/01/2021Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - NA Safety and Pharmacokinetics in subjects with diffuse cutaneous systemicsclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Immunoglobulina Normale Umana per somministrazione sottocutanea
Product Code: [IgPro20]
INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE
Trade Name: Privigen
Product Name: immunoglobulina Normale Umana per somministrazione endovenosa
Product Code: [IgPro10]
INN or Proposed INN: immunoglobulina normale umana
CSL BEHRING GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
12EUCTR2018-003149-41-GB
(EUCTR)
15/05/201930/07/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;Italy;United Kingdom
13NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringUnknown status18 YearsN/AAll14N/AUnited States