Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis

Alpha Mannosidosis Clinical Trial

Official title:
A Single Center, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of rhLAMAN (Recombinant Human Alpha-mannosidase or Lamazym) for the Treatment of Patients With Alpha-mannosidosis.

Status Completed

Clinical Trial Summary

This is a single-center, open-label, dose escalation study of patients with alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients will continue weekly treatment at the designated dose until the Safety Committee approves transfer to the rhLAMAN-03 protocol.

It is the hypothesis that Lamazym is safe to use.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01268358
Study type	Interventional
Source	Chiesi Farmaceutici S.p.A.
Contact
Status	Completed
Phase	Phase 1
Start date	October 2010
Completion date	January 2011

View Details

See also
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Unknown status	`NCT01285700` - Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis	Phase 2
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Completed	`NCT01891422` - Longitudinal Studies of the Glycoproteinoses