ETB115 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
60再生不良性貧血7

60. 再生不良性貧血


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002814-29-IT
(EUCTR)
14/06/201924/05/2021SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemiaSOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral ]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE
Product Name: Eltrombopag
Product Code: [ETB115]
INN or Proposed INN: 00319301
Other descriptive name: Eltrombopag
Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India
2EUCTR2015-003166-91-GB
(EUCTR)
22/05/201905/07/2017A phase II dose escalation study: use of eltrombopag in pediatric patientswith severe aplastic anemia or recurrent aplastic anemiaA phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
3EUCTR2015-003166-91-NL
(EUCTR)
14/11/201808/08/2017A phase II dose escalation study: use of eltrombopag in pediatric patients with severe aplastic anemia or recurrent aplastic anemiaA phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
4EUCTR2015-003166-91-PT
(EUCTR)
15/12/201713/07/2017A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia.A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
5EUCTR2016-002814-29-HU
(EUCTR)
07/09/201705/07/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
6EUCTR2016-002814-29-NL
(EUCTR)
21/07/201729/03/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months.SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
7EUCTR2016-002814-29-ES
(EUCTR)
21/03/201716/12/2016SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR First-line severe aplastic anaemia
MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of