Trials / Completed
CompletedNCT01681953
A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Zymenex A/S · Industry
- Sex
- All
- Age
- 5 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamazym | ERT, i.v. infusions weekly |
| DRUG | Placebo | Infusions weekly |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2012-09-10
- Last updated
- 2020-08-03
Locations
6 sites across 5 countries: Denmark, France, Germany, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT01681953. Inclusion in this directory is not an endorsement.