- Trials with a EudraCT protocol (29)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
29 result(s) found for: Sulfatase.
Displaying page 1 of 2.
EudraCT Number: 2004-002743-27 | Sponsor Protocol Number: TKT024EXT | Start Date*: 2004-12-23 | |||||||||||
Sponsor Name:Shire Human Genetic Therapies INC. | |||||||||||||
Full Title: An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy | |||||||||||||
Medical condition: Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) GB (Completed) SE (Completed) IT (Completed) ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004143-13 | Sponsor Protocol Number: SHP-609-302 | Start Date*: 2015-03-19 | ||||||||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc. | ||||||||||||||||||
Full Title: An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction with Elaprase® in Patients with Hunter Syndrome... | ||||||||||||||||||
Medical condition: Hunter syndrome and cognitive impairment | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male | |||||||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) FR (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2011-000212-25 | Sponsor Protocol Number: HGT-HIT-046 | Start Date*: 2012-01-05 | |||||||||||
Sponsor Name:Shire HGT Inc | |||||||||||||
Full Title: An Open-Label Extension of Study HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Intrathecal Idursulfase-IT Administered in Conjunction with Intravenous Elaprase® in Pediatric Pati... | |||||||||||||
Medical condition: Treatment of Hunter syndrome and cognitive impairment | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-006044-22 | Sponsor Protocol Number: HGT-ELA-038 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT) | |||||||||||||
Full Title: A Multi-Center, Open-Label Study Evaluating Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Enzyme Replacement Therapy | |||||||||||||
Medical condition: Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome) | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-020048-36 | Sponsor Protocol Number: HGT-HIT-045 | Start Date*: 2011-01-31 | |||||||||||
Sponsor Name:Shire HGT, Inc | |||||||||||||
Full Title: A Phase I/II, Randomized, Safety and Ascending Dose Ranging Study of Intrathecal Idursulfase-IT administered in conjunction with intravenous Elaprase in Pediatric Patients with Hunter Syndrome and ... | |||||||||||||
Medical condition: Treatment of Hunter syndrome and cognitive impairment | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-003200-14 | Sponsor Protocol Number: JR-141-GS31 | Start Date*: 2022-05-16 | |||||||||||
Sponsor Name:JCR Pharmaceuticals Co., Ltd. | |||||||||||||
Full Title: A Phase III study of JR-141 in Mucopolysaccharidosis type II (Hunter Syndrome) patients. | |||||||||||||
Medical condition: Mucopolysaccharidosis type II | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2013-002885-38 | Sponsor Protocol Number: HGT-HIT-094 | Start Date*: 2013-10-22 | |||||||||||
Sponsor Name:Shire HGT Inc | |||||||||||||
Full Title: A Controlled,Randomized,Two-arm,Open-label,Assessor-blinded,Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in Pediatric Patients with Hunter Syndrome and... | |||||||||||||
Medical condition: Long-term treatment of Hunter syndrome and cognitive impairment | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-001453-26 | Sponsor Protocol Number: MPS protocol 08-06-07 | Start Date*: 2007-07-02 | |||||||||||||||||||||
Sponsor Name: | |||||||||||||||||||||||
Full Title: Natural course, effects of enzyme therapy and health economic aspects in patients with mucopolysaccharidosis type I, II and VI. Long-term folloe-up of untreated patients and patients receiving com... | |||||||||||||||||||||||
Medical condition: Mucopolysaccharidosis type I, II and VI. | |||||||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: NL (Ongoing) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-015984-15 | Sponsor Protocol Number: HGT-SAN-055 | Start Date*: 2010-03-25 | ||||||||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT) | ||||||||||||||||||
Full Title: A Phase I/II Safety, Tolerability, Ascending Dose and Dose Frequency Study of Recombinant Human Heparan-N-sulfatase (rhHNS) Intrathecal Administration via an Intrathecal Drug Delivery Device in Pat... | ||||||||||||||||||
Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA) | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: GB (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2014-003960-20 | Sponsor Protocol Number: SHP-610-201 | Start Date*: 2015-02-18 | ||||||||||||||||
Sponsor Name:Shire human Genetic Therapies, Inc. | ||||||||||||||||||
Full Title: A Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in... | ||||||||||||||||||
Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA) | ||||||||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: ES (Completed) DE (Prematurely Ended) NL (Completed) GB (Prematurely Ended) FR (Completed) IT (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2021-005200-35 | Sponsor Protocol Number: DNLI-E-0007 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Denali Therapeutics Inc. | |||||||||||||
Full Title: A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp (DNL310) vs Idursulfase in Pediatric and Young Adults Participants With Neuronopathic ... | |||||||||||||
Medical condition: Mucopolysaccharidosis Type II [MPS II] | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2011-002044-28 | Sponsor Protocol Number: HGT-MLD-070 | Start Date*: 2012-06-14 | |||||||||||
Sponsor Name:Shire Human Genetics Therapies Inc | |||||||||||||
Full Title: A Phase I/II, Multicenter, Open-label, Dose Escalation Study of HGT-1110 Administered Intrathecally in Children with Metachromatic Leukodystrophy | |||||||||||||
Medical condition: Treatment of Metachromatic Leukodystrophy | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-021348-16 | Sponsor Protocol Number: HGT-SAN-067 | Start Date*: 2011-02-09 | ||||||||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc | ||||||||||||||||||
Full Title: An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA) | ||||||||||||||||||
Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA) | ||||||||||||||||||
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Population Age: Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: GB (Prematurely Ended) NL (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2017-001730-26 | Sponsor Protocol Number: 205756 | Start Date*: 2017-10-30 | |||||||||||
Sponsor Name:Orchard Therapeutics (Europe) Ltd | |||||||||||||
Full Title: A single arm, open label, clinical study of cryopreserved autologous CD34+ cells transduced with lentiviral vector containing human ARSA cDNA OTL-200, for the treatment of early onset Metachromatic... | |||||||||||||
Medical condition: Metachromatic Leukodystrophy | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-004909-27 | Sponsor Protocol Number: DNLI-E-0002 | Start Date*: 2020-07-22 | |||||||||||
Sponsor Name:Denali Therapeutics Inc. | |||||||||||||
Full Title: A PHASE 1/2, MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL310 IN PEDIATRIC SUBJECTS WITH HUNTER SYNDROME | |||||||||||||
Medical condition: Hunter Syndrome (Mucopolysaccharidosis Type II [MPS II]) | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2011-004410-42 | Sponsor Protocol Number: C11-09 | Start Date*: 2012-11-26 | |||||||||||||||||||||
Sponsor Name:Inserm | |||||||||||||||||||||||
Full Title: A phase I/II, open labeled, monocentric study of direct intracranial administration of a replication deficient adeno-associated virus gene transfer vector serotype rh.10 expressing the human ARSA c... | |||||||||||||||||||||||
Medical condition: Early onset forms of MLD | |||||||||||||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: FR (Completed) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2012-003775-20 | Sponsor Protocol Number: HGT-MLD-071 | Start Date*: 2013-09-11 | |||||||||||
Sponsor Name:Shire Human Genetics Therapies Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited | |||||||||||||
Full Title: An Open-label Extension of Study HGT-MLD-070 Evaluating Long Term Safety and Efficacy of Intrathecal Administration of HGT-1110 in Patients with Metachromatic Leukodystrophy | |||||||||||||
Medical condition: Treatment of Metachromatic Leukodystrophy | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2013-003450-24 | Sponsor Protocol Number: HGT-SAN-093 | Start Date*: 2014-04-09 | ||||||||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc | ||||||||||||||||||
Full Title: A Randomized, Controlled, Open-label, Multicenter, Phase IIb Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in ... | ||||||||||||||||||
Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA) | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: DE (Completed) GB (Completed) ES (Completed) NL (Completed) IT (Completed) FR (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2019-002051-42 | Sponsor Protocol Number: R119861 | Start Date*: 2019-10-25 | |||||||||||
Sponsor Name:University of Manchester | |||||||||||||
Full Title: A phase I-II, study of autologous CD34+ haematopoietic stem cells transduced ex vivo with CD11b lentiviral vector encoding for human SGSH in patients with mucopolysaccharidosis type IIIA (MPS IIIA,... | |||||||||||||
Medical condition: MPS IIIA, mucopolysaccharidosis type IIIA | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2011-005240-10 | Sponsor Protocol Number: C/24/2011 | Start Date*: 2012-03-27 | |||||||||||
Sponsor Name:Imperial College London | |||||||||||||
Full Title: A phase II, open label, preoperative study to assess the efficacy of the novel steroid sulfatase inhibitor Irosustat in postmenopausal women with early oestrogen receptor positive breast cancer. | |||||||||||||
Medical condition: Breast Cancer, ER positive, early | |||||||||||||
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Population Age: Adults, Elderly | Gender: Female | ||||||||||||
Trial protocol: GB (Prematurely Ended) | |||||||||||||
Trial results: View results |
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