44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
| 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 | EUCTR2012-002062-13-DE (EUCTR) | 14/03/2013 | 13/09/2012 | A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis | A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis | granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2012-002062-13-IT (EUCTR) | 28/01/2013 | 11/01/2013 | A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS | A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS | granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | United States;Turkey;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2012-002062-13-GB (EUCTR) | 18/01/2013 | 23/08/2012 | A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis | A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis | granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: MabThera® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom | ||
| 4 | NCT01613599 (ClinicalTrials.gov) | June 20, 2012 | 4/6/2012 | An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Rituximab | Genentech, Inc. | NULL | Completed | 18 Years | N/A | All | 100 | United States |