Tak-079 (DrugBank: -)
3 diseases| 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 | 2 |
| 49 | 全身性エリテマトーデス | 1 |
| 63 | 特発性血小板減少性紫斑病 | 4 |
| 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 | EUCTR2019-003383-47-IT (EUCTR) | 12/08/2020 | 25/09/2020 | A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - | Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: TAK-079 Product Code: [TAK-079, TSF-021, TSF79] INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 Product Name: metilprdnisolone Product Code: [-] INN or Proposed INN: METILPREDNISOLONE Other descriptive name: methylprednisolone Product Name: difenidramina Product Code: [NA] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Other descriptive name: diphenhydramine hydrochloride Product Name: paracetamolo Product Code: [acetominofene] INN or Proposed INN: PARACETAMOLO Other descriptive name: acetaminophen | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Serbia;Canada;Spain;Poland;Italy | ||
| 2 | NCT04159805 (ClinicalTrials.gov) | January 14, 2020 | 8/11/2019 | A Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis | A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis | Myasthenia Gravis | Drug: TAK-079;Drug: TAK-079 Placebo | Takeda | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States;Canada;Italy;Poland;Serbia;Spain |
| 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 | NCT03724916 (ClinicalTrials.gov) | November 26, 2018 | 18/10/2018 | A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic | Drug: TAK-079;Drug: TAK-079 Placebo | Millennium Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1 | United States |
| 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 | EUCTR2019-004103-12-DE (EUCTR) | 27/11/2020 | 02/04/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Millennium Pharmaceuticals, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia;Germany | ||
| 2 | NCT04278924 (ClinicalTrials.gov) | November 9, 2020 | 19/2/2020 | Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Participants With Persistent/Chronic Primary Immune Thrombocytopenia | A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: Placebo;Drug: TAK-079 | Millennium Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | United States;Bulgaria;Croatia;Germany;Italy;Slovenia;Ukraine |
| 3 | EUCTR2019-004103-12-HR (EUCTR) | 25/09/2020 | 23/11/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Millennium Pharmaceuticals, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia | ||
| 4 | EUCTR2019-004103-12-SI (EUCTR) | 16/09/2020 | 28/04/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Millennium Pharmaceuticals, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine |