RhLAMAN ( DrugBank: Rhlaman )


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21

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
Target_
size
PhaseCountries
1EUCTR2016-001988-36-IT
(EUCTR)
12/01/201805/11/2020A study, conducted in several sites, with a duration of 2 years to evaluate the Safety and Efficacy of a new drug named velmanase alfa used in children with Alpha-Mannosidosis below 6 years of ageA 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-Mannosidosis - A study, conducted in several sites, with a duration of 2 years to evaluate the Safety and Efficacy Alfa-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: Velmanase alfa
Product Code: [rhLAMAN]
INN or Proposed INN: VELMANASE ALFA
Other descriptive name: recombinant human alpha-mannosidase
CHIESI FARMACEUTICI S.P.A.NULLNot RecruitingFemale: yes
Male: yes
3Phase 2France;Denmark;Austria;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
5EUCTR2012-000979-17-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
6EUCTR2013-000336-97-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
7EUCTR2013-000321-31-DK
(EUCTR)
07/06/201307/06/2013A long-term safety trial of repeated Velmanase Alfa treatment of subjects with Alpha-MannosidosisA multi-center, un-controlled, open-labeled trial of the long-term safety of Velmanase Alfa aftercaretreatment of subjects with alpha-Mannosidosis whom previously participated in Velmanase Alfa - trials - Phase IIIb Treatement of 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: Velmanase Alfa
Product Code: rhLAMAN
INN or Proposed INN: velmanase alfa
Other descriptive name: recombinant human alpha-mannosidase
Chiesi Farmaceutici S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Phase 3Poland;Denmark
8EUCTR2012-000979-17-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
9EUCTR2012-000979-17-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
10EUCTR2012-000979-17-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
11EUCTR2012-000979-17-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
12EUCTR2011-004355-40-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
13EUCTR2011-004355-40-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
14EUCTR2011-004355-40-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
15EUCTR2011-004355-40-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
16EUCTR2011-004355-40-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
17NCT01285700
(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
18EUCTR2010-022085-26-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
19EUCTR2010-022084-36-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
20NCT01268358
(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
21EUCTR2013-000321-31-PL
(EUCTR)
21/02/2018A long-term safety trial of repeated Velmanase Alfa treatment of subjects with Alpha-Mannosidosis A multi-center, un-controlled, open-labeled trial of the long-term safety of Velmanase Alfa aftercare treatment of subjects with alpha-Mannosidosis whom previously participated in Velmanase Alfa - trials - Phase IIIb Treatement of 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: Velmanase Alfa
Product Code: rhLAMAN
INN or Proposed INN: velmanase alfa
Other descriptive name: recombinant human alpha-mannosidase
Chiesi Farmaceutici S.p.A.NULLNA Female: yes
Male: yes
5 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPoland;Denmark