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Avalglucosidase Alfa Extension Study

NCT02032524

CompletedPhase 2

Sponsor: Genzyme, a Sanofi Company

Conditions: Glycogen Storage Disease Type II Pompe Disease

Interventions: Avalglucosidase Alfa

Countries: United States, Belgium, Denmark, France, Germany, Netherlands, United Kingdom

Primary Objective: Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa Secondary Objective: Long-term effect of avalglucosidase alfa on pharmacodynamic variables

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

Participants with Pompe disease who previously completed an avalglucosidase study.

The participant and/or their parent/legal guardian is willing and able to provide signed informed consent, and the participant, if \<18 years of age, was willing to provide assent if deemed able to do so.

The participant (and participant's legal guardian if participant is \<18 years of age) must have had the ability to comply with the clinical protocol.

The participant, if female and of childbearing potential, had to have a negative pregnancy test \[urine beta-human chorionic gonadotropin\] at baseline.

Exclusion criteria:

The participant was concurrently participating in another clinical study using investigational treatment.

The participant, in the opinion of the Investigator, was unable to adhere to the requirements of the study.

The participant had clinically significant organic disease (with the exception of symptoms relating to Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precluded participation in the study or potentially decreases survival.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (17)

Phoenix, Arizona, United States
Jacksonville, Florida, United States
Kansas City, Kansas, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Fairfax, Virginia, United States
Leuven, Belgium
København Ø, Denmark
Nice, France
Paris, France
Mainz, Germany
München, Germany
Münster, Germany
Rotterdam, Netherlands
Newcastle upon Tyne, United Kingdom