109. Atypical hemolytic uremic syndrome
[
23 clinical trials,
17 drugs（DrugBank:
3 drugs),
1 target gene / 7 target pathways ]
Searched query = "Atypical hemolytic uremic syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03999840 | December 2019 | 4 November 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 | Not recruiting | 12 Years | N/A | All | 12 | Phase 2 | Italy |
| 2 | NCT03518203 | August 3, 2018 | 28 October 2019 | Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients | Early Intervention With Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome (TMA/aHUS)-Associated Multiple Organ Dysfunction Syndrome (MODS) in Hematopoietic Stem Cell Transplant (HCT) Recipients | Thrombotic Microangiopathies;Atypical Hemolytic Uremic Syndrome;Multiple Organ Dysfunction Syndrome | Drug: Eculizumab | Children's Hospital Medical Center, Cincinnati | Recruiting | N/A | N/A | All | 21 | Phase 2 | United States | |
| 3 | EUCTR2017-002057-11-PL | 15/02/2018 | 21 May 2018 | A study to investigate the safety and efficacy of study drug OMS721 in adults and adolescents with Atypical Hemolytic Uremic Syndrome. | A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents. | Atypical Hemolytic Uremic Syndrome (aHUS) 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 Code: OMS721 Drug Product 185 mg/mL Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 185- Product Code: OMS721 Drug Product 185 mg/mL Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 185- | Omeros Corporation | Authorised | Female: yes Male: yes | 80 | Phase 3 | United States;Taiwan;Poland;Lithuania | |||
| 4 | NCT03303313 | September 19, 2017 | 9 October 2018 | 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 | Not recruiting | 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 | 15/09/2017 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: cemdisiran Current Sponsor code: ALN-62643 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- | Alnylam Pharmaceuticals, Inc. | 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 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-000064-15-GB | 14/09/2017 | 25 June 2018 | A study of Safety and Efficacy of Coversin in adult aHUS subjects | A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects | Atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 20.0 Level: PT Classification code 10018932 Term: Haemolytic uraemic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Coversin Product Code: rVA576 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Coversin Current Sponsor code: rVA576 Other descriptive name: COVERSIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 18- | Akari Therapeutics Plc, | Authorised | Female: yes Male: yes | 10 | Phase 2 | United Kingdom | |||
| 7 | NCT03131219 | August 31, 2017 | 22 October 2019 | Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) | Biological: ALXN1210 | Alexion Pharmaceuticals | Recruiting | N/A | 17 Years | All | 28 | Phase 3 | United States;Belgium;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom | |
| 8 | EUCTR2017-001082-24-LV | 18/08/2017 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: cemdisiran Current Sponsor code: ALN-62643 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- | Alnylam Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Estonia;Macedonia, the former Yugoslav Republic of;Canada;Romania;Lithuania;Georgia;Albania;Latvia;Moldova, Republic of;Sweden;Bosnia and Herzegovina | |||
| 9 | EUCTR2016-002499-29-GB | 18/05/2017 | 1 October 2018 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) 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 Code: ALXN1210 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Current Sponsor code: ALXN1210 Other descriptive name: Ravulizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Alexion Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden | |||
| 10 | EUCTR2016-004129-18-GB | 17/03/2017 | 5 June 2017 | An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study | Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 20.0 Level: PT Classification code 10018932 Term: Haemolytic uraemic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: PT Classification code 10034042 Term: Paroxysmal nocturnal haemoglobinuria System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Coversin Product Code: rVA576 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: COVERSIN Current Sponsor code: rVA576 Other descriptive name: COVERSIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 18- | Akari Therapeutics Plc | Authorised | Female: yes Male: yes | 50 | Phase 3 | Argentina;Poland;Netherlands;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03829449 | March 13, 2017 | 11 March 2019 | rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | Paroxysmal Nocturnal Hemoglobinuria;Atypical Hemolytic Uremic Syndrome | Drug: rVA576 (Coversin) | AKARI Therapeutics | Recruiting | 18 Years | N/A | All | 50 | Phase 3 | Poland | |
| 12 | EUCTR2016-002027-29-GB | 24/11/2016 | 21 August 2017 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.0 Level: LLT Classification code 10019515 Term: Hemolytic uremic syndrome System Organ Class: 100000012947 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Alexion Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 55 | Phase 3 | France;United States;Spain;Austria;Australia;Japan;United Kingdom;Korea, Republic of | |||
| 13 | NCT02574403 | November 2015 | 16 December 2017 | Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS | Multicentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome | Drug: eculizumab | Nantes University Hospital | Not recruiting | 3 Years | N/A | All | 60 | Phase 4 | France | |
| 14 | NCT02464891 | June 4, 2015 | 16 December 2017 | Complement Inhibition in aHUS Dialysis Patients | An Open-label Phase 2 Study to Assess the Effect of C5aR Antagonist Therapy by CCX168 Oral Administration on ex Vivo Thrombus Formation and Disease Activity in ESRD Patients With Atypical Hemolytic Uremic Syndrome | Atypical Hemolytic Uremic Syndrome | Drug: CCX168 | Mario Negri Institute for Pharmacological Research | ChemoCentryx | Not recruiting | 18 Years | N/A | All | 6 | Phase 2 | Italy |
| 15 | EUCTR2014-001032-11-LT | 30/09/2014 | 28 February 2019 | A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies. | A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. | Three forms of thrombotic microangiopathies (TMA): - atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA - thrombotic thrombocytopenic purpura (TTP) MedDRA version: 20.0 Level: PT Classification code 10043645 Term: Thrombotic microangiopathy System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: OMS721 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Product Code: OMS721 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not yet available Current Sponsor code: OMS721 Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 185- | Omeros Corporation | Authorised | Female: yes Male: yes | 89 | Phase 2 | United States;Hong Kong;Taiwan;Poland;Malaysia;Belgium;Thailand;Singapore;Lithuania;Bulgaria;New Zealand;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT01757431 | May 16, 2012 | 16 December 2017 | The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) | Drug: Eculizumab | Alexion Pharmaceuticals | Not recruiting | N/A | N/A | All | 2 | Phase 2 | Japan | ||
| 17 | EUCTR2010-020326-18-GB | 19/10/2010 | 12 May 2014 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 14.0 Level: LLT Classification code 10019515 Term: Hemolytic uremic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: eculizumab Current Sponsor code: h5G1.1-mAb Other descriptive name: Anti-C5 antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | ALEXION PHARMACEUTICALS, INC. | Not Recruiting | Female: yes Male: yes | 60 | France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom | ||||
| 18 | NCT01193348 | September 2010 | 19 October 2017 | An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome | An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome | Atypical Hemolytic-Uremic Syndrome | Drug: Eculizumab | Alexion Pharmaceuticals | Not recruiting | 1 Month | 18 Years | All | 22 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;United Kingdom | |
| 19 | NCT01194973 | July 2010 | 16 December 2017 | An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome | An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome | Atypical Hemolytic-Uremic Syndrome | Drug: Eculizumab | Alexion Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 44 | Phase 2 | United States;Belgium;France;Germany;Italy;Spain;United Kingdom | |
| 20 | NCT00838513 | July 2009 | 19 October 2017 | Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS) | An Open-label, Multi-center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (AHUS) | Atypical Hemolytic Uremic Syndrome | Drug: eculizumab | Alexion Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 15 | Phase 2 | Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT00844428 | July 2009 | 19 October 2017 | Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS | An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS) | Atypical Hemolytic Uremic Syndrome | Drug: eculizumab | Alexion Pharmaceuticals | Not recruiting | 12 Years | 17 Years | All | 5 | Phase 2 | Canada;France;Germany;Italy;Netherlands;Sweden;United Kingdom;Austria;Spain;Switzerland;United States | |
| 22 | NCT00844545 | May 2009 | 19 October 2017 | Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS | An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome | Drug: Eculizumab | Alexion Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 16 | Phase 2 | United States;Austria;France;Germany;United Kingdom;Italy;Netherlands;Spain;Sweden;Switzerland | |
| 23 | NCT00844844 | May 2009 | 19 October 2017 | Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS | An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome | Drug: Eculizumab | Alexion Pharmaceuticals | Not recruiting | 12 Years | 17 Years | All | 1 | Phase 2 | United States;Austria;France;Germany;United Kingdom;Canada;Italy;Netherlands;Spain;Sweden;Switzerland |