Sudden Infant Death: Clinical Trials

7 completed. 7 Phase 2, 4 Phase 1, 3 Phase 3.

By phase and status

Phase	Trials	Status
Phase 2	7	Completed 7
Phase 1	4	Completed 4
Phase 3	3	Completed 3

Follow Sudden Infant Death: new trials by email Literature Review of Sudden Infant Death trials Research Report on Sudden Infant Death

Trials (filtered) newest first · largest first

All 7 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome) RGX-121 - Mucopolysaccharidosis Type II (MPS II)	Phase 1 / Phase 2	Completed	REGENXBIO Inc.	6	2021-03-11	2025-01-28
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment idursulfase-IT, No IT treatment - Hunter Syndrome	Phase 2 / Phase 3	Completed	Shire	58	2014-03-24	2021-06-11
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment Idursulfase-IT, Elaprase - Hunter Syndrome	Phase 1 / Phase 2	Completed	Takeda	15	2010-08-01	2025-08-06
To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients GC1111_0.5mg/kg, GC1111_1.0mg/kg, Elaprase_0.5mg/kg - Mucopolysaccharidosis II	Phase 1 / Phase 2	Completed	Green Cross Corporation	31	2010-05-01	2012-02-14
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase® Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg) - Hunter Syndrome	Phase 1 / Phase 2	Completed	Shire	16	2009-11-18	2021-06-28
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase Idursulfase - Hunter Syndrome, Mucopolysaccharidosis II (MPS II)	Phase 2 / Phase 3	Completed	Shire	94	2004-09-13	2021-06-10
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II) Iduronate-2-sulfatase enzyme replacement therapy, iduronate-2-sulfatase enzyme replacement therapy, Placebo - Mucopolysaccharidosis II	Phase 2 / Phase 3	Completed	Shire	96	2003-09-18	2021-06-10

Narrower conditions

Mucopolysaccharidosis II (7)  ·  Lysosomal Storage Diseases (4)  ·  Mucopolysaccharidoses (1)

Broader conditions

Carbohydrate Metabolism, Inborn Errors (7)  ·  Congenital, Hereditary, and Neonatal Diseases and Abnormalities (7)  ·  Connective Tissue Diseases (7)  ·  Death (7)  ·  Death, Sudden (7)  ·  Genetic Diseases, Inborn (7)  ·  Genetic Diseases, X-Linked (7)  ·  Heredodegenerative Disorders, Nervous System (7)  ·  Infant Death (7)  ·  Intellectual Disability (7)  ·  Metabolic Diseases (7)  ·  Metabolism, Inborn Errors (7)  ·  Mucinoses (7)  ·  Nervous System Diseases (7)  ·  Neurobehavioral Manifestations (7)

Interventions

idursulfase (3)  ·  Iduronate Sulfatase (1)

Sponsors

Shire (4)  ·  Green Cross Corporation (1)  ·  REGENXBIO Inc. (1)  ·  Takeda (1)

Countries

United States (6)  ·  United Kingdom (5)  ·  Canada (4)  ·  Brazil (2)  ·  France (2)  ·  Germany (2)  ·  Spain (2)  ·  Australia (1)  ·  Italy (1)  ·  Mexico (1)  ·  Romania (1)  ·  South Korea (1)  ·  Sweden (1)

Results publications

PMID 21150784, PMID 22929184, PMID 23497636, PMID 23837440, PMID 33874971, PMID 35588317, PMID 35961250, PMID 36027721, PMID 37915038

NIH funding

2004 (1)