11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| 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Gravis, Generalized | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp | Withdrawn | 18 Years | N/A | All | 0 | Phase 2/Phase 3 | Belgium;Netherlands |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 |