Trials / Completed
CompletedNCT01268358
Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Zymenex A/S · Industry
- Sex
- All
- Age
- 5 Years – 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamazym | Lamazym, ERT, infusion weekly |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2010-12-30
- Last updated
- 2020-08-03
Source: ClinicalTrials.gov record NCT01268358. Inclusion in this directory is not an endorsement.