Elaprase ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病24

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
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PhaseCountries
1EUCTR2021-005200-35-CZ
(EUCTR)
05/08/202224/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2;Phase 3Colombia;Argentina;United States;Czechia;United Kingdom;Spain;Canada;Czech Republic;Sweden;Netherlands;Turkey;Belgium;Brazil;Mexico;Italy;Australia;France;Germany
2NCT05058391
(ClinicalTrials.gov)
April 21, 202224/9/2021A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in IndiaA 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 Population With Hunter Syndrome (Mucopolysaccharidosis II)Hunter SyndromeBiological: ElapraseShireNULLRecruitingN/AN/AAll5Phase 4India
3EUCTR2014-004804-31-DE
(EUCTR)
12/04/201606/08/2015A long-term study on changes in height and weight of children with MPS II receiving Elaprase and who started the treatment before the age of 6 years.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 Years of Age Hunter syndrome (Mucopolysaccharidosis II, [MPS II]);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Elaprase
INN or Proposed INN: IDURSULFASE
Shire Human Genetic Therapies, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 4United States;Serbia;Philippines;Saudi Arabia;Malaysia;Thailand;Costa Rica;Oman;Dominican Republic;Germany;Vietnam
4NCT02455622
(ClinicalTrials.gov)
October 28, 201520/5/2015Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of AgeA 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 Years of AgeHunter SyndromeDrug: Elaprase for intravenous (IV) infusionTakedaTakeda Development Center Americas, Inc.Active, not recruitingN/A6 YearsMale21Phase 4United States;Dominican Republic;Germany;Malaysia;Philippines;Serbia;Thailand;Vietnam;Oman;Saudi Arabia
5NCT02412787
(ClinicalTrials.gov)
October 28, 20151/4/2015Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094An 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 and Cognitive ImpairmentHunter SyndromeDrug: Idursulfase-IT;Drug: ElapraseShireNULLActive, not recruitingN/A18 YearsMale49Phase 2/Phase 3United States;Australia;Canada;France;Mexico;Spain;United Kingdom;Argentina;Colombia
6EUCTR2014-004143-13-ES
(EUCTR)
09/04/201509/02/2015An extension peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentAn 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 and Cognitive Impairment Hunter syndrome and cognitive impairment
MedDRA version: 18.0;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10056917;Term: Hunter's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
42United States;Mexico;Canada;Argentina;Spain;Colombia;United Kingdom
7EUCTR2014-004143-13-GB
(EUCTR)
19/03/201530/01/2015An extension peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentAn 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 and Cognitive Impairment Hunter syndrome and cognitive impairment
MedDRA version: 20.1;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10056917;Term: Hunter's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
54Phase 2;Phase 3United States;France;Mexico;Canada;Argentina;Spain;Australia;Colombia;United Kingdom
8NCT02055118
(ClinicalTrials.gov)
March 24, 201417/1/2014Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive ImpairmentA 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 Early Cognitive ImpairmentHunter SyndromeBiological: idursulfase-IT;Other: No IT treatmentShireNULLCompletedN/A18 YearsMale58Phase 2/Phase 3United States;Australia;Canada;France;Mexico;Spain;United Kingdom;Argentina;Colombia
9EUCTR2013-002885-38-ES
(EUCTR)
26/11/201308/10/2013Peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentA 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 early Cognitive Impairment. Treatment of Hunter syndrome and cognitive impairment
MedDRA version: 16.0;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASA
Other descriptive name: idursulfase-IT
Shire HGT IncNULLNot RecruitingFemale: no
Male: yes
42Phase 2;Phase 3United States;Mexico;Argentina;Spain;United Kingdom
10EUCTR2013-002885-38-GB
(EUCTR)
22/10/201311/09/2013Peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentA 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 Early Cognitive Impairment. Long-term treatment of Hunter syndrome and cognitive impairment
MedDRA version: 20.0;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire HGT IncNULLNot Recruiting Female: no
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Mexico;Canada;Argentina;Spain;Australia;Germany;Colombia;United Kingdom
11NCT01602601
(ClinicalTrials.gov)
April 9, 201217/5/2012A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723A Study to Test the Possibility of Cross Reaction of the Antibodies Induced by the ELAPRASE (R) to GSK2788723 ELAPRASE is a Trade Mark Owned by a Third PartyMucopolysaccharidosis IIDrug: Idursulfase;Drug: GSK2788723GlaxoSmithKlineNULLCompletedN/AN/AAll10N/AJapan
12EUCTR2011-000212-25-GB
(EUCTR)
05/01/201224/02/2011An extension to the safety, tolerability and preliminary efficacy study of Idursulfase-IT in patients with Hunter syndrome associated with learning disabilityAn 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 Patients with Hunter Syndrome and Cognitive Impairment Treatment of Hunter syndrome and cognitive impairment
MedDRA version: 20.1;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase(12S)-IT
Product Code: 12S-IT
INN or Proposed INN: idursulfase
Other descriptive name: Idursulfase-IT
Shire HGT IncNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
15Phase 1;Phase 2United States;Canada;United Kingdom
13EUCTR2010-020048-36-GB
(EUCTR)
31/01/201117/06/2010A safety, tolerability and preliminary efficacy study of idursulfase-IT in patients with Hunter syndrome associated with learning disabilityA 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 Cognitive Impairment Treatment of Hunter syndrome and cognitive impairment
MedDRA version: 14.1;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase (I2S)-IT
Product Code: I2S-IT
INN or Proposed INN: NA
Other descriptive name: Idursulfase-IT
Shire HGT, IncNULLNot Recruiting Female: no
Male: yes
20 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Kingdom
14NCT01506141
(ClinicalTrials.gov)
August 1, 201015/12/2011Extension 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 ImpairmentAn 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 Patients With Hunter Syndrome and Cognitive ImpairmentHunter SyndromeDrug: Idursulfase-IT;Drug: ElapraseShireNULLActive, not recruiting3 Years18 YearsMale25Phase 1/Phase 2United States;Canada;United Kingdom
15NCT01301898
(ClinicalTrials.gov)
May 201022/2/2011To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome PatientsRandomized, Single-blind, Active-controlled, Phase 1/2 Study to Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) PatientsMucopolysaccharidosis IIDrug: GC1111_0.5mg/kg;Drug: GC1111_1.0mg/kg;Drug: Elaprase_0.5mg/kgGreen Cross CorporationNULLCompleted6 Years35 YearsMale31Phase 1/Phase 2Korea, Republic of
16NCT00920647
(ClinicalTrials.gov)
November 18, 200912/6/2009A 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®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 Cognitive ImpairmentHunter SyndromeOther: Control;Drug: Idursulfase IT (1 mg);Drug: Idursulfase IT (10 mg);Drug: Idursulfase IT (30 mg)ShireNULLCompleted3 Years18 YearsMale16Phase 1/Phase 2United States;United Kingdom
17EUCTR2007-001453-26-NL
(EUCTR)
02/07/200713/11/2009Natural 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 commercially available Aldurazyme, Elaprase and Naglazyme.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 commercially available Aldurazyme, Elaprase and Naglazyme. Mucopolysaccharidosis type I, II and VI.
MedDRA version: 12.0;Level: LLT;Classification code 10028095;Term: Mucopolysaccharidosis IV
MedDRA version: 12.0;Classification code 10056886;Term: Mucopolysaccharidosis I
MedDRA version: 12.0;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II
Trade Name: Elaprase
Product Name: idursulfase
INN or Proposed INN: IDURSULFASE
Other descriptive name: Elaprase
Trade Name: Naglazyme
Product Name: Naglazyme
INN or Proposed INN: GALSULFASE
Trade Name: Aldurazyme
Product Name: Aldurazyme
INN or Proposed INN: LARONIDASE
Other descriptive name: Aldurazyme
NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Netherlands
18EUCTR2011-000212-25-Outside-EU/EEA
(EUCTR)
19/02/2014An extension to the safety, tolerability and preliminary efficacy study of Idursulfase-IT in patients with Hunter syndrome associated with learning disabilityAn 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 Patients with Hunter Syndrome and Cognitive Impairment Treatment of Hunter syndrome and cognitive impairment
MedDRA version: 16.1;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase(I2S)-IT
Product Code: I2S-IT
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire HGT IncNULLNAFemale: no
Male: yes
15Canada;United States
19EUCTR2014-004143-13-FR
(EUCTR)
16/03/2017An extension peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentAn 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 and Cognitive Impairment Hunter syndrome and cognitive impairment
MedDRA version: 19.1;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.1;Level: LLT;Classification code 10056917;Term: Hunter's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire Human Genetic Therapies, Inc.NULLNAFemale: no
Male: yes
54Phase 2;Phase 3United States;France;Mexico;Canada;Argentina;Spain;Australia;Colombia;United Kingdom
20EUCTR2021-005200-35-NL
(EUCTR)
11/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Sweden
21EUCTR2007-006044-22-PL
(EUCTR)
21/04/2008A 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 - not availableA 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 - not available Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome)
MedDRA version: 10.1;Level: PT;Classification code 10056889;Term:
Trade Name: Elaprase 2mg/ml
Product Name: Idursulfase (I2S)
Product Code: I2S
INN or Proposed INN: Idursulfase
Other descriptive name: Idursulfase
Shire Human Genetic Therapies, Inc. (Shire HGT)NULLNot RecruitingFemale: no
Male: yes
30Phase 4Poland
22EUCTR2021-005200-35-DE
(EUCTR)
27/04/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Netherlands;Germany;Sweden
23EUCTR2021-005200-35-FR
(EUCTR)
20/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Sweden
24EUCTR2013-002885-38-FR
(EUCTR)
02/05/2016Peadiatric study of Idursulfase-IT with Elaprase® in patients with Hunter Syndrome and early cognitive impairmentA 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 Early Cognitive Impairment. Long-term treatment of Hunter syndrome and cognitive impairment
MedDRA version: 19.0;Level: PT;Classification code 10056889;Term: Mucopolysaccharidosis II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Idursulfase-IT
Product Code: HGT-2310
INN or Proposed INN: IDURSULFASE
Other descriptive name: idursulfase-IT
Shire HGT IncNULLNot RecruitingFemale: no
Male: yes
54Phase 2;Phase 3United States;France;Mexico;Argentina;Spain;Australia;Germany;United Kingdom