ACICLOVIR ( DrugBank: Aciclovir )

3 diseases
告示番号疾患名（ページ内リンク）臨床試験数
13多発性硬化症／視神経脊髄炎1
28全身性アミロイドーシス1
60再生不良性貧血1

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,342 /  薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02205489
(ClinicalTrials.gov)		October 201429/7/2014Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADASingle Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADARelapsing-remitting Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamolGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth58Phase 4Belgium;France;Netherlands;Spain

28. 全身性アミロイドーシス

臨床試験数 : 261 /  薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2021-000037-14-IT
(EUCTR)		21/01/202226/11/2021A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standardof Care in Mayo Stage IV Subjects with Light Chain (AL) AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains.Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits ofabnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, andhepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]		Product Name: Birtamimab
Product Code: [Birtamimab]
INN or Proposed INN: BIRTAMIMAB
Other descriptive name: Humanized IgG1 kappa antiamyloid
Product Name: paracetamolo Zentiva Italia
Product Code: [NA]
INN or Proposed INN: PARACETAMOLO
Trade Name: Bortezomib Accord
Product Name: Bortezomib Accord
Product Code: [Bortezomib Accord]
INN or Proposed INN: BORTEZOMIB
Other descriptive name: Bortezomib D-mannitol
Product Name: Zirtec
Product Code: [NA]
INN or Proposed INN: CETIRIZINA DICLORIDRATO
Other descriptive name: NA
Product Name: Aciclin
Product Code: [NA]
INN or Proposed INN: ACICLOVIR		Prothena Biosciences LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		150Phase 3United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Germany;Netherlands;Korea, Republic of

60. 再生不良性貧血

臨床試験数 : 235 /  薬物数 : 381 - (DrugBank : 83) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 160
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2011-005152-34-ES
(EUCTR)		26/03/201222/11/2011Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis.
MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]		INN or Proposed INN: ACICLOVIR
Other descriptive name: ACICLOVIR
INN or Proposed INN: AMIKACIN
Other descriptive name: AMIKACIN
INN or Proposed INN: AMPHOTERICINE B, LIPOSOME
Other descriptive name: AMPHOTERICINE B, LIPOSOME
INN or Proposed INN: CASPOFUNGIN ACETATE
Other descriptive name: CASPOFUNGIN ACETATE
INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: CIPROFLOXACIN
INN or Proposed INN: TRIMETHOPRIM SULFATE
Other descriptive name: TRIMETHOPRIM SULFATE
INN or Proposed INN: SULFAMETH		José Miguel Cisneros HerrerosNULLNot RecruitingFemale: yes
Male: yes		Phase 3Spain