Expanded Access to Velmanase Alfa
Primary Purpose
Alpha-Mannosidosis
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Velmanase Alfa
Sponsored by
About this trial
This is an expanded access trial for Alpha-Mannosidosis
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04959240
First Posted
July 1, 2021
Last Updated
September 22, 2023
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT04959240
Brief Title
Expanded Access to Velmanase Alfa
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
5. Study Description
Brief Summary
Individual patient expanded access requests may be considered for patients who have no other treatment options.
Detailed Description
Expanded access may provide access for treatment prior to approval by the local regulatory agency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alpha-Mannosidosis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Velmanase Alfa
Other Intervention Name(s)
Lamzede, Lamazym, rhLAMAN, recombinant human alpha-mannosidase
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Expanded Access
Phone
(888) 661-9260
Email
GRD.EAP@chiesi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials
Email
clinicaltrials_info@chiesi.com
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to Velmanase Alfa
We'll reach out to this number within 24 hrs