65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details

臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCT2031210309	20/12/2022	13/09/2021	RALPID	Phase 2 study of the efficacy and safety of sirolumus in patients with primary immunodeficiency	Primary immunodeficiency PID, ALPS, APDS, CTLA4, IPEX, lymphoproliferative disease, enterocolitis, c ...	Administer sirolimustablets or granules once a daily. Initial dose: 2mg (tablet), 0.049 mg/kg or 0.03 ...	Imai Kohsuke	NULL	Recruiting	>= 2month old	Not applicable	Both	10	Phase 2	Japan
2	NCT05104723 (ClinicalTrials.gov)	March 24, 2022	2/11/2021	Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease With Inflammatory Complications	A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of Tofacitinib for Chronic Granulom ...	Chronic Granulomatous Disease;Inflammatory Gastrointestinal Disease;Inflammatory Skin Disease;Inflam ...	Drug: XELJANZ (tofacitinib)	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Enrolling by invitation	18 Years	N/A	All	20	Phase 1/Phase 2	United States
3	NCT04370795 (ClinicalTrials.gov)	March 24, 2022	30/4/2020	Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency ...	Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency ...	Severe Combined Immunodeficiency (SCID)	Drug: Sirolimus;Drug: Busulfan;Drug: Horse -Anti-thymocyte;Drug: G-CSF;Radiation: Total Body Irradia ...	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Enrolling by invitation	3 Years	40 Years	All	30	Phase 1/Phase 2	United States
4	NCT05189925 (ClinicalTrials.gov)	March 24, 2022	12/1/2022	NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Dis ...	NADPH Oxidase Correction in mRNA Transfected Granulocyte-enriched Cells in Chronic Granulomatous Dis ...	Chronic Granulomatous Disease;Infection	Biological: gp91 Grans	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Recruiting	18 Years	75 Years	Male	25	Phase 1	United States
5	EUCTR2021-000227-13-BG (EUCTR)	07/03/2022	02/12/2021	A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-02212 ...	A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Eval ...	Hereditary angioedema due to C1-Inhibitor Deficiency (Type I or Type II) MedDRA version: 23.1;Level: ...	Product Name: PHVS416 Product Code: PHA-022121 INN or Proposed INN: Not established Other descriptive n ...	Pharvaris Netherlands BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	United States;Canada;Poland;Israel;Bulgaria;Germany;United Kingdom
6	NCT05070455 (ClinicalTrials.gov)	March 1, 2022	23/9/2021	An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ ( ...	An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ ( ...	Primary Immune Deficiency	Biological: Asceniv™	ADMA Biologics, Inc.	NULL	Not yet recruiting	2 Years	11 Years	All	12	Phase 4	NULL
7	NCT05259917 (ClinicalTrials.gov)	March 1, 2022	4/2/2022	A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of ...	A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the E ...	Hereditary Angioedema	Drug: Placebo;Drug: KVD900 600 mg;Drug: KVD900 300 mg	KalVista Pharmaceuticals, Ltd.	NULL	Not yet recruiting	12 Years	N/A	All	114	Phase 3	NULL
8	NCT04965597 (ClinicalTrials.gov)	March 2022	21/6/2021	Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of ...	Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Mar ...	Bone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Ap ...	Drug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T ...	Fred Hutchinson Cancer Research Center	Blood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow ...	Recruiting	1 Year	49 Years	All	40	Phase 2	United States
9	NCT05047185 (ClinicalTrials.gov)	March 2022	7/9/2021	Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With He ...	A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Eval ...	Hereditary Angioedema;Hereditary Angioedema Type I;Hereditary Angioedema Type II;Hereditary Angioede ...	Drug: PHA-022121;Drug: Placebo	Pharvaris Netherlands B.V.	NULL	Recruiting	18 Years	75 Years	All	30	Phase 2	United States;Canada;United Kingdom
10	EUCTR2021-003327-15-NL (EUCTR)	21/02/2022	19/01/2022	Thymosin-a1 in immunodeficiency associated mood disorders	An open-label, 8-week, proof of concept trial on thymosin-a1 (thymalfasin) in the treatment of prima ...	Primary immunodeficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Thymalfasin Product Name: Thymafalsin INN or Proposed INN: THYMALFASIN Other descriptive na ...	Erasmus MC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Netherlands

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