Palifermin ( DrugBank: Palifermin )


5 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2
36表皮水疱症1
38スティーヴンス・ジョンソン症候群1
39中毒性表皮壊死症1
65原発性免疫不全症候群2

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01712945
(ClinicalTrials.gov)
June 201219/10/2012Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple SclerosisKeratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple SclerosisMultiple SclerosisDrug: Palifermin;Drug: AlemtuzumabCambridge University Hospitals NHS Foundation TrustNULLTerminated18 Months50 YearsAll40Phase 1/Phase 2United Kingdom
2EUCTR2011-005606-30-GB
(EUCTR)
25/04/201202/04/2012Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Kepivance
Product Name: Kepivance
INN or Proposed INN: Palifermin
Trade Name: MabCampath
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: anti-CD52 monoclonal antibody
Cambridge University Hospitals NHS Foundation Trust and University of CambridgeNULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00881556
(ClinicalTrials.gov)
August 20, 200914/4/2009Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)A Pilot Study of Reduced Intensity Conditioning (RIC) and Allogeneic Stem Cell Transplantation (ALLOSCT) In Children With Recessive Dystrophic Epidermolysis Bullosa (RDEB)Epidermolysis BullosaDrug: Palifermin;Drug: Fludarabine;Drug: Busulfan;Drug: Lorazepam;Drug: Alemtuzumab;Drug: TacrolimusColumbia UniversityNULLTerminatedN/A21 YearsAll3Early Phase 1United States

38. スティーヴンス・ジョンソン症候群


臨床試験数 : 17 薬物数 : 29 - (DrugBank : 9) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 101
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02037347
(ClinicalTrials.gov)
October 201013/1/2014Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal NecrolysisPalifermin Treatment of Toxic Epidermal NecrolysisToxic Epidermal Necrolysis;Stevens-Johnson SyndromeDrug: PaliferminBrett KingSwedish Orphan BiovitrumTerminated18 YearsN/AAll1Phase 1/Phase 2United States

39. 中毒性表皮壊死症


臨床試験数 : 13 薬物数 : 19 - (DrugBank : 8) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02037347
(ClinicalTrials.gov)
October 201013/1/2014Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal NecrolysisPalifermin Treatment of Toxic Epidermal NecrolysisToxic Epidermal Necrolysis;Stevens-Johnson SyndromeDrug: PaliferminBrett KingSwedish Orphan BiovitrumTerminated18 YearsN/AAll1Phase 1/Phase 2United States

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01306019
(ClinicalTrials.gov)
September 25, 201226/2/2011Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)Lentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age With X-Linked Severe Combined ImmunodeficiencyX-linked Severe Combined Immunodeficiency (XSCID)Drug: Palifermin;Drug: Busulfan;Biological: Ex vivo culture and transduction of the patient's autologous CD34+ HSC with lentivirus vector VSV-G pseudotyped CL20- 4i-EF1alpha-hgammac-OPT vectorNational Institute of Allergy and Infectious Diseases (NIAID)NULLSuspended2 Years40 YearsMale19Phase 1/Phase 2United States
2NCT03315078
(ClinicalTrials.gov)
April 201216/10/2017Lentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age With X-Linked Severe Combined ImmunodeficiencyLentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age With X-Linked Severe Combined ImmunodeficiencyX-Linked Combined Immunodeficiency DiseasesBiological: CD34+ HSCs transduced with the lentivirus vector, VSV-G pseudotyped CL20-4i-EF1a-h?c-OPT;Drug: Palifermin;Drug: BusulfanNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting2 Years40 YearsAll13Phase 1/Phase 2United States