Daratumumab coformulato con ialuronidasi umana ricombinante (rHuPH20) ( DrugBank: Daratumumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス1

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
1EUCTR2016-001737-27-IT
(EUCTR)
01/03/201817/06/2021A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis - ANDROMEDA AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis)
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: daratumumab coformulato con ialuronidasi umana ricombinante (rHuPH20)
Product Code: [JnJ 54767414]
INN or Proposed INN: Daratumumab
Other descriptive name: HUMAX-CD38
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of