Trials / Terminated
TerminatedNCT01526785
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
A Phase 4 Open Label, Prospective Study in Patients With Pompe Disease to Evaluate The Efficacy and Safety of Alglucosidase Alfa Produced at the 4000L Scale
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alglucosidase alfa | 4000 L alglucosidase alfa administered by IV infusion at the same dose and dose regimen used for the patient's routine treatment prior to the study for 52 weeks. |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2012-02-06
- Last updated
- 2015-12-08
- Results posted
- 2015-10-27
Locations
51 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01526785. Inclusion in this directory is not an endorsement.