Elaprase: Clinical Trials

6 completed, 1 active not recruiting, 1 unknown, 1 withdrawn. 5 Phase 2, 3 Phase 3, 3 Phase 4, 1 Phase 1.

By phase and status

Phase	Trials	Status
Phase 2	5	Completed 3, Active not recruiting 1, Unknown 1
Phase 3	3	Completed 2, Active not recruiting 1
Phase 4	3	Completed 2, Withdrawn 1
Phase 1	1	Completed 1

Follow Elaprase: new trials by email Literature Review of Elaprase trials Research Report on Elaprase

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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
Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment Idursulfase-IT, Elaprase - Hunter Syndrome	Phase 2 / Phase 3	Active not recruiting	Takeda	6	2024-03-05	2025-11-06
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II) ELAPRASE, Rituximab, Methotrexate - Mucopolysaccharidosis (MPS), Hunter Syndrome	Phase 4	Withdrawn	Takeda		2023-02-28	2025-12-09
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India Elaprase - Hunter Syndrome	Phase 4	Completed	Takeda	5	2022-04-21	2025-01-23
Study of Idursulfase-beta (GC1111) in Hunter Syndrome idursulfase beta, idursulfase - Mucopolysaccharidosis II	Phase 2	Unknown	Green Cross Corporation	20	2016-12-01	2016-01-26
Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094 Idursulfase-IT, Elaprase - Hunter Syndrome	Phase 2 / Phase 3	Completed	Shire	56	2015-04-14	2025-06-19
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
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients Idursulfase - Hunter Syndrome		Completed	Shire	26	2008-10-14	2021-06-08
Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy Idursulfase - Hunter Syndrome, Mucopolysaccharidosis II	Phase 4	Completed	Shire	28	2007-12-31	2021-06-08
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

Conditions studied

Mucopolysaccharidosis II (9)  ·  Sudden Infant Death (4)  ·  Lysosomal Storage Diseases (3)  ·  Mucopolysaccharidoses (1)

Sponsors

Shire (4)  ·  Takeda (4)  ·  Green Cross Corporation (1)

Countries

United States (5)  ·  United Kingdom (4)  ·  Brazil (3)  ·  Canada (3)  ·  France (2)  ·  Australia (1)  ·  Germany (1)  ·  India (1)  ·  Mexico (1)  ·  Poland (1)  ·  Spain (1)  ·  Taiwan (1)

Results publications

PMID 23837440, PMID 25902842, PMID 28243577, PMID 33874971, PMID 35588317, PMID 35961250, PMID 37915038

NIH funding

2014 (1), 2023 (1)