LAMAZYM ( DrugBank: Lamazym )


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23

19. ライソゾーム病


臨床試験数 : 854 薬物数 : 716 - (DrugBank : 105) / 標的遺伝子数 : 69 - 標的パスウェイ数 : 190
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT02998879
(ClinicalTrials.gov)
December 201625/11/2016Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-MannosidosisA 24-month Multicenter, Open-label Phase II Trial Investigating the Safety and Efficacy of Repeated Velmanase Alfa (Recombinant Human Alpha-mannosidase) Treatment in Pediatric Patients Below 6 Years of Age With Alpha-MannosidosisAlpha-MannosidosisDrug: Velmanase Alfa (e.g. Lamazym)Chiesi Farmaceutici S.p.A.CromsourceCompletedN/A6 YearsAll5Phase 2Austria;Denmark;France;Germany;Italy
2NCT02478840
(ClinicalTrials.gov)
February 20159/2/2015Evaluation of Long-term Efficacy of Treatment With LamazymA Single Center, Open Label Clinical Trial Investigating the Long-term Efficacy of rhLAMAN (Recombinant Human Alpha-mannosidase or Lamazym) Treatment in Subjects With Alpha-Mannosidosis Who Previously Participated in Lamazym TrialsAlpha-MannosidosisDrug: LamazymZymenex A/SNULLCompletedN/AN/AAll18Phase 3Denmark
3EUCTR2013-000336-97-DK
(EUCTR)
30/01/201503/12/2014A trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis who previously participated in Lamazym-trialsA multi-center, un-controlled, open-labeled trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis Alpha-Mannosidosis
MedDRA version: 20.0;Level: LLT;Classification code 10032658;Term: Other specified disorders of carbohydrate transport and metabolism;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: Velmanase alfa
Other descriptive name: LAMAZYM
Chiesi Farmaceutici S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
13Phase 3France;Denmark
4EUCTR2014-003950-15-DK
(EUCTR)
22/01/201525/11/2014Medical research trial for testing drug treatment of alpha-MannosidosisA single center, open label clinical trial investigating the long-term efficacy of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) treatment in subjects with alpha-Mannosidosis who previously participated in Lamazym trials alpha-Mannosidosis
MedDRA version: 17.1;Level: LLT;Classification code 10032658;Term: Other specified disorders of carbohydrate transport and metabolism;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: recombinant human lysosomal alpha-mannosidase
Other descriptive name: LAMAZYM
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
Denmark
5NCT01908712
(ClinicalTrials.gov)
August 201316/7/2013Lamazym Aftercare Study FR Designed to Provide Treatment for French PatientsA Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym TrialsAlpha-MannosidosisDrug: LamazymChiesi Farmaceutici S.p.A.NULLEnrolling by invitationN/AN/AAll10Phase 3France
6EUCTR2012-000979-17-SE
(EUCTR)
30/07/201307/06/2013A Placebo-Controlled phase 3 trial of repeated Lamazym treatment of subjects with Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with alpha-Mannosidosis - Phase III Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: Lamazym
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
25Phase 3Spain;Belgium;Denmark;Germany;Sweden
7EUCTR2013-000336-97-FR
(EUCTR)
26/06/201328/09/2015A trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis who previously participated in Lamazym-trialsA multi-center, un-controlled, open-labeled trial of the long-term safety of Lamazym aftercare treatment of subjects with alpha-Mannosidosis who previously participated in Lamazym-trials Treatment of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: recombinant human lysosomal alpha-mannosidase
Other descriptive name: LAMAZYM
Zymenex A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
7 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Denmark
8NCT01908725
(ClinicalTrials.gov)
June 201312/6/2013Lamazym Aftercare StudyA Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym TrialsAlpha-MannosidosisDrug: LamazymChiesi Farmaceutici S.p.A.NULLActive, not recruitingN/AN/AAll5Phase 3Denmark
9EUCTR2012-000979-17-BE
(EUCTR)
26/03/201307/01/2013A Placebo-Controlled phase 3 trial of repeated Lamazym treatment of subjects with Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with alpha-Mannosidosis - Phase III Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: recombinant human alpha-mannosidase
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
25Phase 3Spain;Belgium;Denmark;Germany;Sweden
10EUCTR2012-000979-17-ES
(EUCTR)
27/02/201309/01/2013A Placebo-Controlled phase 3 trial of repeated Lamazym treatment of subjects with Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with alpha-Mannosidosis - Phase III Treatment of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: Lamazym
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
25Phase 3Spain;Denmark;Germany;Sweden;Belgium
11EUCTR2012-000979-17-DE
(EUCTR)
17/12/201209/07/2012A Placebo-Controlled phase 3 trial of repeated Lamazym treatment of subjects with Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with alpha-Mannosidosis - Phase III Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
20Phase 3Spain;Belgium;Denmark;Germany;Sweden
12EUCTR2012-000979-17-DK
(EUCTR)
06/08/201206/08/2012A Placebo-Controlled phase 3 trial of repeated Lamazym treatment of subjects with Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with alpha-Mannosidosis - Phase III Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
20Phase 3Spain;Belgium;Denmark;Germany;Sweden
13NCT01681953
(ClinicalTrials.gov)
August 201222/8/2012A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-MannosidosisA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis.Alpha-MannosidosisDrug: Lamazym;Drug: PlaceboZymenex A/SEuropean CommissionCompleted5 Years35 YearsAll25Phase 3Denmark;France;Germany;Poland;United Kingdom
14EUCTR2011-004355-40-DE
(EUCTR)
23/07/201218/01/2012A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Spain;Belgium;Denmark;Germany;United Kingdom
15EUCTR2011-004355-40-ES
(EUCTR)
19/04/201217/04/2012A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: alfa-manosidadas humana recombinante
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Belgium;Spain;Denmark;Germany;United Kingdom
16EUCTR2011-004355-40-GB
(EUCTR)
28/03/201214/02/2012A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Spain;Belgium;Denmark;Germany;United Kingdom
17EUCTR2011-004355-40-BE
(EUCTR)
30/01/201219/01/2012A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Spain;Belgium;Denmark;Germany;United Kingdom
18EUCTR2011-004355-40-DK
(EUCTR)
17/01/201218/01/2012A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis.A multi-center, open-label trial of the long-term efficacy and safety of Lamazym for the treatment of patients with alpha-Mannosidosis. - Phase 2b Treatement of Alpha-Mannosidosis;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Name: Lamazym
Product Code: rhLAMAN
Other descriptive name: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
9Phase 2Spain;Belgium;Denmark;Germany;United Kingdom
19NCT01681940
(ClinicalTrials.gov)
January 201222/8/2012Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-MannosidosisA Multi-Center, Open-Label Trial of the Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-MannosidosisAlpha-MannosidosisDrug: LamazymZymenex A/SEuropean CommissionCompleted5 Years21 YearsAll10Phase 2Belgium;Denmark;Spain;United Kingdom
20NCT01285700
(ClinicalTrials.gov)
January 201125/1/2011Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosisA Single Center, Randomized, Open-label, Multiple-dose Study of the Efficacy and Long-term Safety of rhLAMAN (Recombinant Human Alpha-mannosidase or Lamazym) for the Treatment of Patients With Alpha-mannosidosis.Alpha MannosidosisDrug: LamazymZymenex A/SEuropean CommissionActive, not recruiting5 Years21 YearsBoth10Phase 2Denmark
21EUCTR2010-022085-26-DK
(EUCTR)
05/10/201023/08/2010A single center, randomized, open-label, multiple-dose study of the efficacy and long-term safety of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) for the treatment of patients with alpha-mannosidosisA single center, randomized, open-label, multiple-dose study of the efficacy and long-term safety of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) for the treatment of patients with alpha-mannosidosis Treatment of alpha-MannosidosisProduct Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
10Denmark
22EUCTR2010-022084-36-DK
(EUCTR)
05/10/201020/08/2010A single center, open-label, dose escalation study of the safety and pharmacokinetics of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) for the treatment of patients with alpha-mannosidosis.A single center, open-label, dose escalation study of the safety and pharmacokinetics of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) for the treatment of patients with alpha-mannosidosis. Treatment of alpha-MannosidosisProduct Name: Lamazym
Product Code: rhLAMAN
INN or Proposed INN: recombinant human alpha-mannosidase
Zymenex A/SNULLNot RecruitingFemale: yes
Male: yes
10Denmark
23NCT01268358
(ClinicalTrials.gov)
October 201029/12/2010Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosisA Single Center, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of rhLAMAN (Recombinant Human Alpha-mannosidase or Lamazym) for the Treatment of Patients With Alpha-mannosidosis.Alpha MannosidosisDrug: LamazymZymenex A/SEuropean CommissionCompleted5 Years20 YearsAll10Phase 1NULL