- Trials with a EudraCT protocol (22)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
22 result(s) found for: Hunter syndrome.
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: 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: 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: 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: 2022-004193-39 | Sponsor Protocol Number: TAK-665-4001 | Start Date*: 2024-12-04 |
Sponsor Name:Takeda Biopharmaceuticals India Pvt. Ltd. | ||
Full Title: A Prospective, Multicenter, Single-arm, Open-label, Interventional Phase IV Study to Evaluate the Safety and Efficacy of Idursulfase (r-DNA Origin) (Elaprase™) in Indian Pediatric and Adult Populat... | ||
Medical condition: Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18 | Gender: Male | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
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: 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 (Ongoing) ES (Ongoing) BE (Ongoing) FR (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2014-004804-31 | Sponsor Protocol Number: SHP-ELA-401 | Start Date*: 2016-04-12 |
Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire), a wholly owned subsidiary of Takeda Pharmaceutical Company Limited | ||
Full Title: A Long-Term, Open-Label, Multicenter, Phase IV Study to Assess Longitudinal Changes on Height and Weight in Patients with MPS II Who Are Receiving Elaprase and Started Treatment With Elaprase at <6... | ||
Medical condition: Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male | |
Trial protocol: DE (Completed) | ||
Trial results: (No results available) |
EudraCT Number: 2015-001235-20 | Sponsor Protocol Number: 14.0189 | Start Date*: 2015-06-05 |
Sponsor Name:St George's University of London | ||
Full Title: Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease | ||
Medical condition: PARTICIPANTS WITH EVIDENCE OF CEREBRAL SMALL VESSEL DISEASE | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2010-019058-42 | Sponsor Protocol Number: LITIO-SUM-FC-002 | Start Date*: 2010-05-26 | |||||||||||
Sponsor Name:AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI | |||||||||||||
Full Title: Safety of sumatriptan in combination with lithium for treatment of cluster headache, Pilot Study,Phase II | |||||||||||||
Medical condition: Cluster Headache | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-000585-61 | Sponsor Protocol Number: ALID02003 | Start Date*: 2015-05-18 | |||||||||||
Sponsor Name:Genzyme, a Sanofi Company | |||||||||||||
Full Title: A Multicenter, Multinational, Open-Label Study of Anti-Laronidase Antibody Formation and Urinary GAG Levels in Patients with Mucopolysaccaridosis I (MPS I) Being Treated with Aldurazyme® (laronidase) | |||||||||||||
Medical condition: Mucopolysaccharidosis I Hurler's Syndrome Hurler-Scheie Syndrome Scheie's Syndrome | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2009-017026-39 | Sponsor Protocol Number: UCBT-002 | Start Date*: 2009-12-28 | |||||||||||
Sponsor Name:Aldagen, Inc | |||||||||||||
Full Title: A PHASE III TRIAL OF ALD-101 ADUVANT THERAPY of UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) IN PATIENTS WITH INBORN ERRORS OF METABOLISM | |||||||||||||
Medical condition: Inborn errors of metabolism | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-011921-15 | Sponsor Protocol Number: UCBT-002 | Start Date*: 2009-06-22 | |||||||||||
Sponsor Name:Aldagen, Inc | |||||||||||||
Full Title: A PHASE III TRIAL OF ALD-101 ADUVANT THERAPY of UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) IN PATIENTS WITH INBORN ERRORS OF METABOLISM | |||||||||||||
Medical condition: Inborn errors of metabolism | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NL (Not Authorised) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2007-001163-30 | Sponsor Protocol Number: ALID02307 | Start Date*: 2015-05-11 | |||||||||||
Sponsor Name:Genzyme, a Sanofi Company | |||||||||||||
Full Title: A trial of antigen-specific immune tolerance induction in mucopolysaccharidosis I (MPS I) patients initiating enzyme replacement therapy with Aldurazyme® (laronidase) | |||||||||||||
Medical condition: Mucopolysaccharidosis I | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-001833-26 | Sponsor Protocol Number: OC000459/019/15 | Start Date*: 2015-07-21 | |||||||||||
Sponsor Name:Atopix Therapeutics Ltd., | |||||||||||||
Full Title: THE EFFECT OF OC000459 ON EOSINOPHILIC AIRWAY INFLAMMATION AND ASTHMA CONTROL IN SUBJECTS WITH REFRACTORY EOSINOPHILIC ASTHMA: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL | |||||||||||||
Medical condition: Severe Eosinophilic Asthma | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-000192-33 | Sponsor Protocol Number: SB-913-1602 | Start Date*: 2018-08-17 | |||||||||||
Sponsor Name:Sangamo Therapeutics, Inc. | |||||||||||||
Full Title: A Phase 1/2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-913, a rAAV2/6-based Gene Transfer in Subjects with Mucopolysaccharidosis II (MPS II) | |||||||||||||
Medical condition: Mucopolysaccharidosis type II (MPS II) | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
Trial results: (No results available) |
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