Trials / Completed
CompletedNCT01908725
Lamazym Aftercare Study
A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamazym i.v. treatment of subjects with alpha-Mannosidosis whom previously participated in Lamazym-trial.
Detailed description
This protocol only concern subjects where compassionate use program was not accepted. Efficacy will be evaluated once yearly to follow the subject's progress in clinical parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamazym | ERT, i.v. infusions weekly |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2022-09-30
- Completion
- 2022-09-30
- First posted
- 2013-07-26
- Last updated
- 2023-07-28
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01908725. Inclusion in this directory is not an endorsement.