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Expanded Access to Velmanase Alfa

Primary Purpose

Alpha-Mannosidosis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Velmanase Alfa
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Alpha-Mannosidosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2021
    Last Updated
    September 22, 2023
    Sponsor
    Chiesi Farmaceutici S.p.A.
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    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

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