Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-20 @ 2:17 AM
Study NCT ID:
NCT01908712
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rhLAMAN-07
Brief Summary:
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.
Detailed Description:
This trial provide aftercare treatment with Lamzede to French patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-000336-97 | EUDRACT_NUMBER | None | View |