Abetimus ( DrugBank: Abetimus )


1 disease
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus12

49. Systemic lupus erythematosus


Clinical trials : 946 Drugs : 722 - (DrugBank : 186) / Drug target genes : 117 - Drug target pathways : 199
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2008-004852-62-IT
(EUCTR)
09/02/200927/01/2009Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITISSafety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS
MedDRA version: 9.1;Level: SOC;Classification code 10028395
MedDRA version: 9.1;Level: LLT;Classification code 10040970
Product Name: ABETIMUS SODIUM
Product Code: LJP394
INN or Proposed INN: RIQUENT
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINULLNot RecruitingFemale: yes
Male: yes
Italy
2EUCTR2006-000674-73-BG
(EUCTR)
14/08/200814/08/2008A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus Sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
Other descriptive name: RIQUENT
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
3EUCTR2006-000674-73-IT
(EUCTR)
12/05/200820/03/2008A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - NDA randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND Systemic lupus erithematosus (SLE) patients with a history of renal disease.
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus
LA JOLLA PHARMACEUTICAL COMPANYNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
4EUCTR2006-000674-73-ES
(EUCTR)
21/02/200803/12/2007ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍAESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
5EUCTR2006-000674-73-DE
(EUCTR)
23/01/200816/10/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
850Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
6EUCTR2006-000674-73-PT
(EUCTR)
11/01/200817/09/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Czech Republic;Hungary;Spain;Bulgaria;Germany;Italy
7EUCTR2006-000674-73-CZ
(EUCTR)
07/01/200825/10/2007A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
730Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy
8EUCTR2006-000674-73-SK
(EUCTR)
09/10/200609/08/2006A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLNot RecruitingFemale: yes
Male: yes
588Phase 3Portugal;Czech Republic;Hungary;Slovakia;Spain;Bulgaria;Germany;Italy
9NCT00390091
(ClinicalTrials.gov)
September 200617/10/2006Study of LJP 394 (Abetimus Sodium) in Lupus PatientsA Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNULLWithdrawn12 Years70 YearsBoth0Phase 2United States
10EUCTR2006-000674-73-HU
(EUCTR)
11/08/200615/06/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
La Jolla Pharmaceutical CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
730Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
11NCT00089804
(ClinicalTrials.gov)
October 200413/8/2004Study of LJP 394 in Lupus Patients With History of Renal DiseaseA Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseLupus Erythematosus, Systemic;Lupus NephritisDrug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered salineLa Jolla Pharmaceutical CompanyNULLTerminated12 Years70 YearsBoth943Phase 3United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro
12NCT00035308
(ClinicalTrials.gov)
November 20012/5/2002Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney DiseaseA Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal DiseaseImmunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus GlomerulonephritisDrug: Abetimus sodium (LJP 394)La Jolla Pharmaceutical CompanyNULLCompleted12 Years70 YearsBoth330Phase 3United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom