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9

19. ライソゾーム病 [臨床試験数:784,薬物数:673(DrugBank:101),標的遺伝子数:68,標的パスウェイ数:184
Searched query = "Lysosomal storage disease", "Lysosomal disease", "Gaucher disease", "Niemann-Pick disease", "Niemann-Pick type C", "GM1-gangliosidosis", "GM1-gangliosidoses", "GM2-gangliosidosis", "GM2-gangliosidoses", "Tay-Sachs disease", "Sandhoff disease", "Krabbe disease", "Metachromatic leukodystrophy", "Multiple-sulfatase deficiency", "Farber disease", "Mucopolysaccharidosis type I", "Mucopolysaccharidosis I", "MPS I", "Hurler syndrome", "Scheie syndrome", "Mucopolysaccharidosis type II", "Mucopolysaccharidosis II", "MPS II", "Hunter syndrome", "Mucopolysaccharidosis type III", "Mucopolysaccharidosis III", "MPS III", "Sanfilippo syndrome", "Mucopolysaccharidosis type IV", "Mucopolysaccharidosis IV", "MPS IV", "MPS IVA", "Morquio syndrome", "Morquio A syndrome", "Mucopolysaccharidosis type VI", "Mucopolysaccharidosis VI", "MPS VI", "Maroteaux-Lamy syndrome", "Mucopolysaccharidosis type VII", "Mucopolysaccharidosis VII", "MPS VII", "Sly syndrome", "Mucopolysaccharidosis type IX", "Mucopolysaccharidosis IX", "MPS IX", "Hyaluronidase deficiency", "Sialidosis", "Galactosialidosis", "Mucolipidosis II", "Mucolipidosis type II", "I-cell disease", "Mucolipidosis III", "Mucolipidosis type III", "Alpha-Mannosidosis", "Alpha-Mannosidase Deficiency", "Beta-Mannosidosis", "Beta-Mannosidase Deficiency", "Fucosidosis", "Aspartylglucosaminuria", "Schindler disease", "Kanzaki disease", "Pompe disease", "Acid lipase deficiency", "Wolman disease", "Cholesterol ester storage disease", "Danon disease", "Free sialic acid storage disease", "Salla disease", "Ceroid lipofuscinosis", "Fabry disease", "Cystinosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
9 / 784 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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
5NCT02998879
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001988-36-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
7EUCTR2013-000336-97-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
8EUCTR2013-000321-31-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
9Phase 3Poland;Denmark
9EUCTR2013-000321-31-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]
Chiesi Farmaceutici S.p.A.NULLNA Female: yes
Male: yes
5Phase 3Poland;Denmark