Clinical Trial Results:
An Open-Label, Multicenter, Multinational, Study of the Safety, Efficacy,
Pharmacokinetics, and Pharmacodynamics of Recombinant Human Acid alpha-
Glucosidase (rhGAA) Treatment in Patients > 6 and <= 36 Months Old with Infantile-Onset
Pompe Disease (Glycogen Storage Disease Type II)
Summary
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EudraCT number |
2004-002168-59 |
Trial protocol |
IT |
Global completion date |
12 Jun 2006
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jun 2016
|
First version publication date |
01 Jun 2016
|
Other versions |
|
Summary report(s) |
AGLU01702 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.