Radamts-13 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 64 | Thrombotic thrombocytopenic purpura | 6 |
| 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 | EUCTR2020-003348-10-GB (EUCTR) | 17/11/2020 | 14/09/2020 | A continuation study to evaluate the prophylactic and on demand treatment of congenital Thrombotic Thrombocytopenic Purpura (cTTP) with the drug TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) | A Phase 3b, prospective, open-label, multicenter, single treatment arm, continuation study of the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw Schulman Syndrome, or hereditary thrombotic thrombocytopenic purpura) - Baxalta TAK-755-3002 Continuation study to 281102 | congenital Thrombotic thrombocytopenic purpura (TTP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase Thrombospondin Type-1 Motifs 13 Product Code: TAK-755 orBAX930 or SHP655 INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs INN or Proposed INN: Apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;Portugal;Serbia;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 2 | JPRN-JapicCTI-194991 | 20/10/2019 | 08/10/2019 | A phase 3, randomized, controlled study of prophylactic and on-demand | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2 period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) | severe congenital thrombotic thrombocytopenicpurpura (cTTP, Upshaw-Schulman Syndrome [USS],hereditary thrombotic thrombocytopenic purpura [hTTP] | Intervention name : rADAMTS-13 INN of the intervention : - Dosage And administration of the intervention : BAX930 is to be reconstituted using all the amount of the accompanying water for reconstitution and injected or dripped slowly intravenously. Normally, 40 (+/-4) international units per kg of body weight is administered at intervals of 1 to 2 weeks or according to the patient's symptoms. The frequency of dosing and dose level can be increased or decreased as appropriate according to the patient's symptoms. Control intervention name : Standrd of Care treatment INN of the control intervention : - Dosage And administration of the control intervention : - | Baxalta now part of Shire(ICCC: IQVIA Services Japan K.K.) | NULL | recruiting | 0 | 70 | BOTH | 4 | Phase 3 | Japan, North America, Europe |
| 3 | EUCTR2018-003775-35-DE (EUCTR) | 18/10/2019 | 30/04/2019 | A Phase 2, randomized, placebo-controlled, double-blind study ofrADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovation GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 4 | NCT03922308 (ClinicalTrials.gov) | October 9, 2019 | 5/4/2019 | Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics,Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment | Acquired Thrombotic Thrombocytopenic Purpura (aTTP) | Other: Placebo;Drug: SHP655;Other: Standard of Care | Shire | NULL | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States;France;Germany;Spain;United Kingdom |
| 5 | EUCTR2018-003775-35-GB (EUCTR) | 03/07/2019 | 13/02/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - Baxalta SHP655-201 | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13) Product Code: SHP 655 (BAX 930) INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 INN or Proposed INN: apadamtase alfa Other descriptive name: BAX930 - RECOMBINANT HUMAN ADAMTS13 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | United States;France;Canada;Spain;Germany;Italy;United Kingdom | ||
| 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 |
| 6 | EUCTR2018-003775-35-ES (EUCTR) | 13/06/2019 | 11/06/2019 | A Phase 2, randomized, placebo-controlled, double-blind study of rADAMTS-13 (SHP655) in the treatment of patients with aTTP | A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment | acquired thrombotic thrombocytopenic purpura (aTTP) MedDRA version: 20.0;Level: PT;Classification code 10043648;Term: Thrombotic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2 | France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland |