109. 非典型溶血性尿毒症症候群 Atypical hemolytic uremic syndrome Clinical trials / Disease details
臨床試験数 : 114 / 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11
| 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 | NCT03999840 (ClinicalTrials.gov) | January 2021 | 25/6/2019 | Eculizumab to Cemdisiran Switch in aHUS | A Phase II, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Cemdisiran (ALN-CC5) Following Withdrawal of Chronic Eculizumab Therapy in Patients With Atypical HUS at High Risk of Recurrence | Atypical Hemolytic Uremic Syndrome | Drug: cemdisiran;Drug: Placebos | Mario Negri Institute for Pharmacological Research | Alnylam Pharmaceuticals | Withdrawn | 12 Years | N/A | All | 0 | Phase 2 | Italy |
| 2 | EUCTR2018-004382-13-IT (EUCTR) | 28/11/2019 | 25/05/2021 | Safety and efficacy of Cemdisiran in athypical hemolytic uremic syndrome | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CEMDISIRAN (ALN-CC5) FOLLOWING WITHDRAWAL OF CHRONIC ECULIZUMAB THERAPY IN PATIENTS WITH ATYPICAL HUS AT HIGH RISK OF RECURRENCE - Eculizumab to Cemdisiran switch in aHUS | Atypical Hemolytic Uremic Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ALN-CC5 Product Code: [ALN-62643] INN or Proposed INN: Cemdisiran | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Italy | ||
| 3 | EUCTR2017-001082-24-SE (EUCTR) | 20/11/2017 | 27/09/2017 | An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injection | A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ALN-CC5 Product Code: ALN-CC5 INN or Proposed INN: cemdisiran | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 4 | NCT03303313 (ClinicalTrials.gov) | September 19, 2017 | 25/9/2017 | A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome | A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients With Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome | Drug: Cemdisiran | Alnylam Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | Bosnia and Herzegovina;Canada;Estonia;Georgia;Latvia;Lithuania;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Serbia;Sweden |
| 5 | EUCTR2017-001082-24-EE (EUCTR) | 15/09/2017 | 16/08/2017 | An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injection | A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ALN-CC5 Product Code: ALN-CC5 INN or Proposed INN: cemdisiran | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 6 | EUCTR2017-001082-24-LT (EUCTR) | 23/08/2017 | 27/06/2017 | An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injection | A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ALN-CC5 Product Code: ALN-CC5 INN or Proposed INN: cemdisiran | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Estonia;Lithuania;India;Canada;Macedonia, the former Yugoslav Republic of;Romania;Albania;Georgia;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 7 | EUCTR2017-001082-24-LV (EUCTR) | 18/08/2017 | 20/06/2017 | An international study at different study sites providing a drug called cemdisiran (ALN-CC5) to patients with Atypical Hemolytic Uremic Syndrome by a subcutaneous injection | A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ALN-CC5 Product Code: ALN-CC5 INN or Proposed INN: cemdisiran | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Estonia;Macedonia, the former Yugoslav Republic of;Canada;Romania;Lithuania;Georgia;Albania;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina |