Who is sponsoring NCT01526785?

NCT01526785 is sponsored by Genzyme, a Sanofi Company.

What condition does NCT01526785 study?

NCT01526785 studies Pompe Disease.

What drugs are being tested in NCT01526785?

Interventions: Alglucosidase alfa.

What is the status of NCT01526785?

NCT01526785 is currently TERMINATED.

Last reviewed 2015-11-09 · How we verify

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

NCT01526785 Phase 4 TERMINATED Results posted

The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 4
Status	TERMINATED
Enrolment	113
Start date	2012-03
Completion	2014-12

Conditions

Pompe Disease

Interventions

Alglucosidase alfa

Primary outcomes

Percentage of Participants Who Were Clinically Stable or Improved at Week 52 — Week 52
Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.

Countries

United States