Metazym ( 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6

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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01303146
(ClinicalTrials.gov)
October 200823/2/2011Efficacy METAZYM for the Treatment Metachromatic Leukodystrophy Treated With Hematopoietic Stem Cell Transplantationand Safety of METAZYM (Recombinant Human Arylsulfatase A or rhASA) for the Treatment of Patients With Late Infantile MLD Who Had Previously Hematopoietic Stem Cell TransplantationMetachromatic LeukodystrophyDrug: rhARSAAssistance Publique - Hôpitaux de ParisEuropean Leukodystrophy Association;Zymenex A/S;ShireCompleted6 MonthsN/ABoth1Phase 2France
2EUCTR2007-006345-40-DK
(EUCTR)
26/08/200814/01/2008A single center, open-label, non-randomized, uncontrolled, multiple-dose study of the efficacy and long-term safety of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of patients with late infantile metachromatic leukodystrophyA single center, open-label, non-randomized, uncontrolled, multiple-dose study of the efficacy and long-term safety of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of patients with late infantile metachromatic leukodystrophy Metachromatic Leukodystrophy (MLD) in late infantile patients
MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy
Product Name: Metazym
Product Code: rhASA
Other descriptive name: recombinant human arylsulfatase A
Shire Pharmaceutical Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
Denmark
3EUCTR2007-007165-20-DK
(EUCTR)
26/02/200814/01/2008A single center, open-label, non-randomized, uncontrolled, multiple-dose study of the efficacy and safety of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of MLD patients with high residual level of voluntary functionA single center, open-label, non-randomized, uncontrolled, multiple-dose study of the efficacy and safety of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of MLD patients with high residual level of voluntary function Metachromatic Leukodystrophy (MLD) in late infantile patients
MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy
Product Name: Metazym
Product Code: rhASA
Other descriptive name: recombinant human arylsulfatase A
Shire Pharmaceuticals Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Denmark
4NCT00633139
(ClinicalTrials.gov)
August 200729/2/2008Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)A Single Center, Open-Label, Non-Randomized, Uncontrolled, Multiple-Dose, Dose Escalation Study of the Safety, Pharmacokinetics, Efficacy and Long Term Safety of HGT-1111 (Recombinant Human Arylsulfatase A [rhASA, Metazym]) for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)Late Infantile Metachromatic LeukodystrophyBiological: Recombinant human Arylsulfatase A (rhASA)ShireNULLCompleted1 Year5 YearsAll13Phase 1/Phase 2Denmark
5NCT00418561
(ClinicalTrials.gov)
January 22, 20074/1/2007Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)A Single Center, Open-label, Non-randomized, Uncontrolled, Multiple-dose, Dose Escalation Study of the Safety, Pharmacokinetics and Efficacy of Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)Metachromatic Leukodystrophy (MLD)Biological: rhASA - Dose Level 1;Biological: rhASA - Dose Level 2;Biological: rhASA - Dose Level 3ShireNULLCompleted1 Year5 YearsAll13Phase 1Denmark
6EUCTR2006-005341-11-DK
(EUCTR)
28/12/200608/11/2006A single center, open-label, non-randomized, uncontrolled, multiple-dose, dose escalation study of the safety, pharmacokinetics and efficacy of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of patients with late infantile metachromatic leukodystrophy (MLD)A single center, open-label, non-randomized, uncontrolled, multiple-dose, dose escalation study of the safety, pharmacokinetics and efficacy of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of patients with late infantile metachromatic leukodystrophy (MLD) Late infantile metachromatic leukodystrophy (MLD)
MedDRA version: 9.1;Level: LLT;Classification code 10024381;Term: Leukodystrophy
Product Name: Metazym
Product Code: rhASA
INN or Proposed INN: Arylsulfatase A
Other descriptive name: Metazym
Shire Pharmaceuticals Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
12Denmark