Myfortic ( DrugBank: - )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス4
66IgA腎症2
162類天疱瘡(後天性表皮水疱症を含む。)1
222一次性ネフローゼ症候群3
228閉塞性細気管支炎2

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00504244
(ClinicalTrials.gov)
July 200718/7/2007Myfortic Versus Azathioprine in Systemic Lupus ErythematosusA Randomized, Multicenter Study to Assess the Efficacy on Diseases Activity of Enteric-coated Mycophenolate Sodium Versus Continuation of Azathioprine in Patients With Systemic Lupus Erythematosus on Azathioprine Maintenance Therapy.Systemic Lupus ErythematosusDrug: switch to Myfortic;Drug: continuation of azathioprineErasmus Medical CenterNovartis PharmaceuticalsTerminated18 YearsN/ABoth12Phase 3Netherlands
2EUCTR2006-002107-13-IT
(EUCTR)
24/11/200609/03/2007A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - NDA randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND Systemic lupus erythematosis
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus
Trade Name: MYFORTIC*50CPR RIV 360MG
INN or Proposed INN: Mycophenolic acid
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
Trade Name: MYFORTIC*50CPR RIV 360MG
INN or Proposed INN: Mycophenolic acid
Trade Name: DELTACORTENE*20CPR 5MG
INN or Proposed INN: Prednisone
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;United Kingdom;France;Spain;Italy;Greece
3EUCTR2005-003070-19-HU
(EUCTR)
25/04/200603/02/2006A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - MylupusA randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus lupus nephritis ( as part of the disease Systemic Lupus Erythematosus)Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080A
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140Phase 2Hungary
4EUCTR2005-002207-16-GB
(EUCTR)
30/09/200516/08/2005A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMADA randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE)Trade Name: Myfortic
Trade Name: Cellcept
Cambridge University Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-016003-26-GB
(EUCTR)
06/05/201017/03/2010RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : MyforticRANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
INN or Proposed INN: mycophenolic acid
Other descriptive name: mycophenolate sodium
Trade Name: Myfortic
Product Name: Myfortic 180mg Tablets
INN or Proposed INN: mycophenolic sodium
Other descriptive name: mycophenolate sodium
Product Name: Prednisolone
INN or Proposed INN: prednisolone
UHB NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United Kingdom
2EUCTR2007-000443-99-DE
(EUCTR)
09/04/200813/11/2008Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis progressive IgA-Nephritis
MedDRA version: 9.1;Level: LLT;Classification code 10029143;Term: Nephritis-glomerular
Trade Name: Myfortic
INN or Proposed INN: Mycophenolat-Natrium
Trade Name: Decortin H
INN or Proposed INN: Prednisolon
Universitätsklinikum UlmNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-001827-12-DE
(EUCTR)
29/12/200512/07/2005Myfortic ® zur Therapie des Bullösen Pemphigoids. Eine offene monozentrische proof-of-concept StudieMyfortic ® zur Therapie des Bullösen Pemphigoids. Eine offene monozentrische proof-of-concept Studie Bullous PemphigoidTrade Name: Myfortic 180 mg
Product Name: Myfortic 180 mg Filmtabletten
Georg-August-Universität Göttingen, Bereich HumanmedizinNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Germany

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01185197
(ClinicalTrials.gov)
September 201013/8/2010Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized StudyMyfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic SyndromeNephrosis, LipoidDrug: Myfortic plus low-dose steroid;Drug: PrednisoloneThe University of Hong KongNULLCompleted18 Years65 YearsAll20Phase 4China
2EUCTR2009-016003-26-GB
(EUCTR)
06/05/201017/03/2010RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : MyforticRANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
INN or Proposed INN: mycophenolic acid
Other descriptive name: mycophenolate sodium
Trade Name: Myfortic
Product Name: Myfortic 180mg Tablets
INN or Proposed INN: mycophenolic sodium
Other descriptive name: mycophenolate sodium
Product Name: Prednisolone
INN or Proposed INN: prednisolone
UHB NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United Kingdom
3NCT01197040
(ClinicalTrials.gov)
October 20097/9/2010Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic SyndromeLow Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic SyndromeNephrotic SyndromeDrug: Prednisone;Drug: acid mycophenolic (Myfortic)Assistance Publique - Hôpitaux de ParisNovartisCompleted18 YearsN/AAll117Phase 3France

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-001290-25-GB
(EUCTR)
14/09/200516/08/2005A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungA 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLung Heart-Lung, bilateral lung and single lung transplant recipientsICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3Trade Name: Certican
Trade Name: Myfortic
St Vincent's HospitalNULLNot RecruitingFemale: yes
Male: yes
320Spain;Austria;Germany;United Kingdom
2EUCTR2004-001290-25-AT
(EUCTR)
14/07/200506/09/2005A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415)A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415) Patients between 18-65 years who have received either a single or bilateral lung transplant or a combined heart-lung transplant and who are suitable to receive triple immunosuppressive therapy with either mycophenolate sodium or everolimus, both arms in combination with cyclosporin and corticosteroids.Product Name: Myfortic
Product Code: ERL080
INN or Proposed INN: Mycophenolate
Trade Name: Certican 0,5 mg Tabletten
Product Name: Certican 0,5
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Certican 0,75mg Tabletten
Product Name: Certican 0,75mg
Product Code: RAD001
INN or Proposed INN: Everolimus
Prof Allan Glanville, St Vincents HospitalNULLNot RecruitingFemale: yes
Male: yes
320Spain;Austria;Germany;United Kingdom