Velmanase alfa

Generic Name
Velmanase alfa
Brand Names
Lamzede
Drug Type
Biotech
Chemical Formula
-
CAS Number
1492823-75-2
Unique Ingredient Identifier
M91TG242P2
Background

Velmanase alfa is a recombinant human lysosomal alpha-mannosidase developed for enzyme replacement therapy to treat alpha-mannosidosis. Alpha-mannosidosis is a rare autosomal recessive lysosomal storage disorder. Patients with alpha-mannosidosis have a genetic mutation that causes a deficiency in the lysosomal enzyme alpha-mannosidase, which is an enzyme res...

Indication

Velmanase alfa is an enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.

Associated Conditions
Non-neurological symptoms
Associated Therapies
-
Clinical Trials
Related News

Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3

Recruiting
Conditions
Alpha-Mannosidosis
Interventions
Drug: Velmanase Alfa
First Posted Date
2023-12-28
Last Posted Date
2024-11-14
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
5
Registration Number
NCT06184503
Locations
🇺🇸

Greenwood Genetic Center, Greenwood, South Carolina, United States

🇺🇸

Nicklaus Children's Hospital, Miami, Florida, United States

Expanded Access to Velmanase Alfa

First Posted Date
2021-07-13
Last Posted Date
2023-09-25
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Registration Number
NCT04959240

Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis

Phase 3
Withdrawn
Conditions
Alpha-Mannosidosis
Interventions
Drug: Velmanase Alfa
Drug: Placebo
First Posted Date
2019-07-24
Last Posted Date
2020-12-08
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Registration Number
NCT04031066

Evaluation of Long-term Efficacy of Treatment With Lamazym

Phase 3
Completed
Conditions
Alpha-Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2015-06-23
Last Posted Date
2020-11-20
Lead Sponsor
Zymenex A/S
Target Recruit Count
18
Registration Number
NCT02478840
Locations
🇩🇰

Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark

Lamazym Aftercare Study

Phase 3
Completed
Conditions
Alpha-Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2013-07-26
Last Posted Date
2023-07-28
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
8
Registration Number
NCT01908725
Locations
🇩🇰

Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark

Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients

Phase 3
Completed
Conditions
Alpha-Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2013-07-26
Last Posted Date
2023-07-28
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
13
Registration Number
NCT01908712
Locations
🇫🇷

Hôpital Femme Mére Enfant - CHU de Lyon, Bron, France

A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis

Phase 3
Completed
Conditions
Alpha-Mannosidosis
Interventions
Drug: Lamazym
Drug: Placebo
First Posted Date
2012-09-10
Last Posted Date
2020-08-03
Lead Sponsor
Zymenex A/S
Target Recruit Count
25
Registration Number
NCT01681953
Locations
🇩🇰

Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark

🇩🇪

Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1, Mainz, Germany

🇫🇷

Hôpital Femme Mère Enfant, Lyon, 59 boulevard Pinel, Bron, France

and more 3 locations

Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis

Phase 2
Completed
Conditions
Alpha-Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2012-09-10
Last Posted Date
2017-03-29
Lead Sponsor
Zymenex A/S
Target Recruit Count
10
Registration Number
NCT01681940
Locations
🇩🇰

Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark

🇧🇪

Kinderneurologie Metabole Ziekten, UZ Brussel, Laarbeeklaan 101, Brussel, Belgium

🇪🇸

Servicio de Pediatría, Hospital Materno Infantil, Reina Sofía, Avda Menéndez Pidal sn, Córdoba, Spain

and more 1 locations

Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis

Phase 2
Conditions
Alpha Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2011-01-28
Last Posted Date
2012-09-26
Lead Sponsor
Zymenex A/S
Target Recruit Count
10
Registration Number
NCT01285700
Locations
🇩🇰

Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark

Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis

Phase 1
Completed
Conditions
Alpha Mannosidosis
Interventions
Drug: Lamazym
First Posted Date
2010-12-30
Last Posted Date
2020-08-03
Lead Sponsor
Zymenex A/S
Target Recruit Count
10
Registration Number
NCT01268358
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