CV-MG01 ( DrugBank: CV-MG01 )

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1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
11	重症筋無力症	4

11. 重症筋無力症

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臨床試験数 : 332 /  薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

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	NCT03165435 (ClinicalTrials.gov)	July 2018	17/5/2017	A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis.	Myasthenia Gravis, Generalized	Biological: CV-MG01;Biological: Placebo	CuraVac	Aepodia;University Hospital, Antwerp	Withdrawn	18 Years	N/A	All	0	Phase 2/Phase 3	Belgium;Netherlands
2	EUCTR2017-000323-27-NL (EUCTR)	03/08/2017	18/04/2017	A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravis	A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study	Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate	CuraVac Europe SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	66	Phase 2;Phase 3	Belgium;Netherlands
3	EUCTR2017-000323-27-BE (EUCTR)	19/06/2017	13/04/2017	A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis	A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study	Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate	CuraVac Europe SA	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2;Phase 3	Belgium;Netherlands
4	NCT02609022 (ClinicalTrials.gov)	March 2016	13/11/2015	Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis	A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis	Myasthenia Gravis	Biological: CV-MG01;Biological: Placebo	CuraVac	Aepodia;University Hospital, Antwerp;Leiden University Medical Center	Completed	18 Years	64 Years	All	24	Phase 1/Phase 2	Belgium