Sandimmun Neoral ( DrugBank: - )


3 diseases
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2
97潰瘍性大腸炎1
226間質性膀胱炎(ハンナ型)1

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
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
2EUCTR2006-006577-25-SE
(EUCTR)
25/07/200711/06/2007A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantationA prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders
MedDRA version: 9.1;Level: LLT;Classification code 10018799;Term: GVHD
Trade Name: Rapamune
Product Name: Rapamune
INN or Proposed INN: SIROLIMUS
Other descriptive name: Rapamycin
Trade Name: Prograf
Product Name: Prograf
INN or Proposed INN: TACROLIMUS
Other descriptive name: FK-506
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Other descriptive name: CsA
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Finland;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-005299-42-FI
(EUCTR)
25/02/200827/12/2007A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDYA randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB
Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)NULLNot RecruitingFemale: yes
Male: yes
100France;Finland;Belgium;Spain

226. 間質性膀胱炎(ハンナ型)


臨床試験数 : 143 薬物数 : 171 - (DrugBank : 56) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-000890-23-SE
(EUCTR)
13/10/200502/08/2005NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine.NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine. Interstitiell cystitTrade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: Ciklosporin
Ingrid EhrénNULLNot RecruitingFemale: yes
Male: yes
15Sweden