Studies
| Study First Submitted Date | 2021-07-01 |
| Study First Posted Date | 2021-07-13 |
| Last Update Posted Date | 2022-07-26 |
| Verification Month Year | July 2022 |
| Verification Date | 2022-07-31 |
| Last Update Posted Date | 2022-07-26 |
Detailed Descriptions
| Sequence: | 20847123 |
| Description | Expanded access may provide access for treatment prior to approval by the local regulatory agency. |
Conditions
| Sequence: | 52493265 |
| Name | Alpha-Mannosidosis |
| Downcase Name | alpha-mannosidosis |
Id Information
| Sequence: | 40388928 |
| Id Source | org_study_id |
| Id Value | Velmanase alfa-EAP |
Interventions
| Sequence: | 52801959 |
| Intervention Type | Drug |
| Name | Velmanase Alfa |
Browse Conditions
| Sequence: | 194716219 | Sequence: | 194716220 | Sequence: | 194716221 | Sequence: | 194716222 | Sequence: | 194716223 | Sequence: | 194716224 | Sequence: | 194716225 |
| Mesh Term | Mannosidase Deficiency Diseases | Mesh Term | alpha-Mannosidosis | Mesh Term | Carbohydrate Metabolism, Inborn Errors | Mesh Term | Metabolism, Inborn Errors | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Lysosomal Storage Diseases | Mesh Term | Metabolic Diseases |
| Downcase Mesh Term | mannosidase deficiency diseases | Downcase Mesh Term | alpha-mannosidosis | Downcase Mesh Term | carbohydrate metabolism, inborn errors | Downcase Mesh Term | metabolism, inborn errors | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | lysosomal storage diseases | Downcase Mesh Term | metabolic diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48618180 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Chiesi Farmaceutici S.p.A. |
Central Contacts
| Sequence: | 12092063 | Sequence: | 12092064 |
| Contact Type | primary | Contact Type | backup |
| Name | Expanded Access | Name | Clinical Trials |
| Phone | (888) 661-9260 | ||
| GRD.EAP@chiesi.com | clinicaltrials_info@chiesi.com | ||
| Role | Contact | Role | Contact |
Eligibilities
| Sequence: | 30949630 |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: – Exclusion Criteria: – |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 253853964 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
Intervention Other Names
| Sequence: | 26833564 | Sequence: | 26833565 | Sequence: | 26833566 | Sequence: | 26833567 |
| Intervention Id | 52801959 | Intervention Id | 52801959 | Intervention Id | 52801959 | Intervention Id | 52801959 |
| Name | Lamzede | Name | Lamazym | Name | rhLAMAN | Name | recombinant human alpha-mannosidase |
Responsible Parties
| Sequence: | 29061974 |
| Responsible Party Type | Sponsor |