SAR421869 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
90網膜色素変性症3
303アッシャー症候群4

90. 網膜色素変性症


臨床試験数 : 147 薬物数 : 176 - (DrugBank : 43) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 110
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-001139-38-PT
(EUCTR)
12/02/201815/11/2017MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC (Locoregionally Advanced Head and Neck Squamous Cell Carcinoma)A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for StageIII-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) - MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC Retinitis Pigmentosa, associated with Ushers Syndrome Type 1B.
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10063396;Term: Usher's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: UshStat (SAR421869)
Product Code: Lentiviral vector containing MYO7A gene
INN or Proposed INN: Lentiviral vector containing the human MY07A gene
Other descriptive name: UshStat
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
704Phase 1;Phase 2United States;France
2EUCTR2012-002574-31-FR
(EUCTR)
25/10/201315/05/2014Study of SAR421869 in Patients With Retinitis Pigmentosa associated with Usher Syndrome Type 1BA Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients with Retinitis Pigmentosa Associated with Usher Syndrome Type 1B Retinitis Pigmentosa, associated with Ushers Syndrome Type 1B.
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10063396;Term: Usher's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: UshStat (SAR421869)
Product Code: Lentiviral vector containing MYO7A gene
INN or Proposed INN: Lentiviral vector containing the human MY07A gene
Other descriptive name: UshStat
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
27Phase 1;Phase 2United States;France
3NCT01505062
(ClinicalTrials.gov)
March 26, 20124/1/2012Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1BA Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1BUsher Syndrome;Retinitis PigmentosaDrug: SAR421869SanofiNULLTerminated6 YearsN/AAll9Phase 1/Phase 2United States;France

303. アッシャー症候群


臨床試験数 : 10 薬物数 : 11 - (DrugBank : 0) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-001139-38-PT
(EUCTR)
12/02/201815/11/2017MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC (Locoregionally Advanced Head and Neck Squamous Cell Carcinoma)A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for StageIII-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) - MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC Retinitis Pigmentosa, associated with Ushers Syndrome Type 1B.
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10063396;Term: Usher's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: UshStat (SAR421869)
Product Code: Lentiviral vector containing MYO7A gene
INN or Proposed INN: Lentiviral vector containing the human MY07A gene
Other descriptive name: UshStat
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
704Phase 1;Phase 2United States;France
2EUCTR2012-002574-31-FR
(EUCTR)
25/10/201315/05/2014Study of SAR421869 in Patients With Retinitis Pigmentosa associated with Usher Syndrome Type 1BA Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients with Retinitis Pigmentosa Associated with Usher Syndrome Type 1B Retinitis Pigmentosa, associated with Ushers Syndrome Type 1B.
MedDRA version: 20.0;Level: PT;Classification code 10038914;Term: Retinitis pigmentosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10063396;Term: Usher's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: UshStat (SAR421869)
Product Code: Lentiviral vector containing MYO7A gene
INN or Proposed INN: Lentiviral vector containing the human MY07A gene
Other descriptive name: UshStat
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
27Phase 1;Phase 2United States;France
3NCT02065011
(ClinicalTrials.gov)
September 12, 201314/2/2014A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1BAn Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1BUsher's SyndromeDrug: Blood draw for the laboratory assessmentSanofiNULLActive, not recruiting18 YearsN/AAll9Phase 1/Phase 2United States;France
4NCT01505062
(ClinicalTrials.gov)
March 26, 20124/1/2012Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1BA Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1BUsher Syndrome;Retinitis PigmentosaDrug: SAR421869SanofiNULLTerminated6 YearsN/AAll9Phase 1/Phase 2United States;France