Expanded Access to Velmanase Alfa NCT04959240

Updated 05/03/2024

Clinical Trial Details — Status: Available

Administrative data
NCT number	NCT04959240
Other study ID #	Velmanase alfa-EAP
Secondary ID
Status	Available
Phase
First received
Last updated

Study information
Verified date	September 2023
Source	Chiesi Farmaceutici S.p.A.
Contact	Expanded Access
Phone	(888) 661-9260
Email	GRD.EAP[@]chiesi.com
Is FDA regulated	No
Health authority
Study type	Expanded Access

Clinical Trial Summary

Individual patient expanded access requests may be considered for patients who have no other treatment options.

Description:

Expanded access may provide access for treatment prior to approval by the local regulatory agency.

Recruitment information / eligibility
Status	Available
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	All
Age group	N/A and older
Eligibility	Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Alpha-Mannosidosis

Intervention

Drug:
• Velmanase Alfa

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

See also
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	Not yet recruiting	`NCT06184503` - Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
	Completed	`NCT01908725` - Lamazym Aftercare Study	Phase 3
	Completed	`NCT02141503` - Clinical Biomarkers in Alpha-mannosidosis
	Recruiting	`NCT02171104` - MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis	Phase 2
	Completed	`NCT01681940` - Long-term Efficacy and Safety of Lamazym for the Treatment of Patients With Alpha-Mannosidosis	Phase 2
	Withdrawn	`NCT04031066` - Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis	Phase 3
	Recruiting	`NCT03333200` - Longitudinal Study of Neurodegenerative Disorders
	Completed	`NCT02478840` - Evaluation of Long-term Efficacy of Treatment With Lamazym	Phase 3
	Completed	`NCT02998879` - Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis	Phase 2
	Completed	`NCT01908712` - Lamazym Aftercare Study FR Designed to Provide Treatment for French Patients	Phase 3
	Completed	`NCT01681953` - A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis	Phase 3
	Terminated	`NCT01372228` - Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders	Phase 1/Phase 2