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Glycogen Storage Disease Type II clinical trials

View clinical trials related to Glycogen Storage Disease Type II.

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NCT ID: NCT01859624 Completed - Pompe Disease Clinical Trials

Albuterol in Individuals With Late Onset Pompe Disease (LOPD)

Start date: June 2012
Phase: Phase 1
Study type: Interventional

Albuterol is a drug approved by the US Food and Drug Administration (FDA) for treating breathing problems such as asthma. Studies have shown that albuterol may be beneficial in improving muscle function in people with late-onset Pompe disease. The purpose of this study is to evaluate whether albuterol is safe and effective for improving muscle function in people with late-onset Pompe disease, whether or not they are receiving enzyme replacement therapy (ERT). For this study, albuterol is considered an investigational drug. The word "investigational" means albuterol is not approved by the FDA for individuals with late-onset Pompe disease.

NCT ID: NCT01758354 Completed - Pompe Disease Clinical Trials

Newborn Screening Assay of Pompe's Disease

Start date: September 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of a newborn screen assay for Pompe disease

NCT ID: NCT01710813 Completed - Pompe Disease Clinical Trials

Alglucosidase Alfa Pompe Safety Sub-Registry

Start date: March 20, 2015
Phase:
Study type: Observational [Patient Registry]

To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment with alglucosidase alfa.

NCT ID: NCT01701154 Completed - Pompe Disease Clinical Trials

The Effects of Respiratory Muscle Strength Training (RMST) on Inspiratory and Expiratory Muscle Strength in Adults and Children With Pompe Disease

Start date: December 2010
Phase:
Study type: Observational

The purpose of the study is to determine if respiratory muscle strength training will be beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe disease.

NCT ID: NCT01556516 Completed - Pompe Disease Clinical Trials

Pregnancy and Birth Outcome in Women With Pompe Disease

Start date: February 2012
Phase: N/A
Study type: Observational

This study explores the outcome and effect of pregnancy on Pompe Disease. The results are expected to guide clinicians in counseling and care of women with Pompe disease, who are planning to become pregnant, and during the pregnancy.

NCT ID: NCT01451879 Completed - Pompe Disease Clinical Trials

Observational Study for Subjects With Pompe Disease Undergoing Immune Modulation Therapies

Start date: October 2008
Phase: N/A
Study type: Observational

Hypothesis: the effectiveness of treatment of Pompe Disease with rhGAA enzyme replacement therapy (ERT) is limited at least in part because patients develop antibodies against the provided rhGAA enzyme. Treatment with immunomodulatory drugs may dampen or eliminate the anti-rhGAA immune response in patients receiving ERT, thereby allowing for greater ERT efficacy. Studying the immune response to rhGAA may provide valuable insight into the role of the immune system in the effectiveness of ERT for Pompe Disease.

NCT ID: NCT01410890 Completed - Pompe Disease Clinical Trials

Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

PAPAYA
Start date: November 3, 2014
Phase: Phase 4
Study type: Interventional

- The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease. - A secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the PK of alglucosidase alfa.

NCT ID: NCT01380743 Completed - Pompe Disease Clinical Trials

Drug-drug Interaction Study

Start date: October 31, 2011
Phase: Phase 2
Study type: Interventional

This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

NCT ID: NCT01288027 Completed - Clinical trials for Pompe Disease (Late-Onset)

Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This is an open-label, multicenter study of participants with late-onset Pompe disease naive to treatment with enzyme replacement therapy (ERT). The primary objective of this study is to evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase alfa treatment in participants with Late-Onset Pompe disease. The secondary objectives are to characterize the disease burden in participants with late-onset Pompe disease and explore imaging, histologic, and functional assessments in these participants and to explore potential plasma or urine biomarkers relative to late-onset Pompe disease and participant's response to treatment with alglucosidase alfa (Myozyme®/Lumizyme®/GZ419829).

NCT ID: NCT01230801 Completed - Pompe Disease Clinical Trials

Safety/Tolerability/Pharmacokinetic (PK)/Pharmacodynamics (PD) Study of BMN701 in Patients With Late-Onset Pompe Disease

Start date: January 17, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered by intravenous infusion every 2 weeks over a 24-week treatment period to patients with late-onset Pompe disease.