51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04137224
(ClinicalTrials.gov)
September 19, 201921/10/2019Safety 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)Diffuse Cutaneous Systemic SclerosisBiological: IgPro20;Biological: IgPro10CSL BehringNULLRecruiting18 YearsN/AAll26Phase 2Australia;France;Germany;Italy;Poland;United Kingdom
2EUCTR2018-003149-41-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
3EUCTR2018-003149-41-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]
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
4EUCTR2018-003149-41-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