VELMANASE ALFA ( DrugBank: Velmanase alfa )


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10

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT04031066
(ClinicalTrials.gov)
January 11, 202117/7/2019Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha MannosidosisA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Velmanase Alfa in Patients With Alpha MannosidosisAlpha-MannosidosisDrug: Velmanase Alfa;Drug: PlaceboChiesi Farmaceutici S.p.A.NULLWithdrawnN/AN/AAll0Phase 3NULL
2EUCTR2016-001988-36-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
3EUCTR2016-001988-36-DE
(EUCTR)
09/08/201714/02/2017A 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 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
INN or Proposed INN: VELMANASE ALFA
Other descriptive name: recombinant human alpha-mannosidase
Chiesi Farmaceutici S.p.A.NULLNot RecruitingFemale: yes
Male: yes
3Phase 2Austria;Denmark;Germany
4EUCTR2016-001988-36-AT
(EUCTR)
10/04/201722/02/2017A 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 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
INN or Proposed INN: VELMANASE ALFA
Other descriptive name: recombinant human alpha-mannosidase
Chiesi Farmaceutici S.p.A.NULLNot RecruitingFemale: yes
Male: yes
3Phase 2Denmark;Austria;Germany
5EUCTR2016-001988-36-FR
(EUCTR)
27/02/201718/09/2020A 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 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
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
3Phase 2France;Austria;Denmark;Germany;Italy
6NCT02998879
(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
7EUCTR2016-001988-36-DK
(EUCTR)
05/10/201611/07/2016A 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 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
INN or Proposed INN: VELMANASE ALFA
Other descriptive name: recombinant human alpha-mannosidase
Chiesi Farmaceutici S.p.A.NULLNot RecruitingFemale: yes
Male: yes
3Phase 2Austria;Denmark;Germany;Italy
8EUCTR2013-000336-97-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
9EUCTR2013-000321-31-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
10EUCTR2013-000321-31-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