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Alglucosidase Alfa Pompe Safety Sub-Registry

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pompe Disease

Intervention: alglucosidase alfa (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Overall contact:
For site information, send an email with site number to, Email: Contact-Us@sanofi.com

Summary

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.

Clinical Details

Official title: A Prospective Safety Sub-Registry to Assess Anaphylaxis and Severe Allergic Reactions, and Severe Cutaneous and Systemic Immune Complex Mediated Reactions With Alglucosidase Alfa Treatment

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: number of patients experience anaphylaxis, severe allergic reactions and/or signals of severe cutaneous and/or systematic immune complex-mediated reactions

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patient must be enrolled in the Pompe Registry;

- Provide a signed patient information and authorization form;

- Have a confirmed diagnosis of Pompe disease (confirmation of diagnosis is defined as

documented GAA enzyme deficiency from any tissue source and/or documentation of 2 GAA gene mutations);

- Be naïve to and plan to be treated with alglucosidase alfa at or prior to enrollment,

or are being treated with alglucosidase alfa. Exclusion Criteria:

- Patients will be excluded if they have received an investigational drug (excluding

alglucosidase alfa) within 30 days prior to signing a Safety Sub-Registry Patient Information and Authorization form, or if they are taking or plan to take any investigational product while enrolled in the Safety Sub-Registry.

Locations and Contacts

For site information, send an email with site number to, Email: Contact-Us@sanofi.com

Investigational Site Number 056001, Gent 9000, Belgium; Recruiting

Investigational Site Number 151747, Fairfax, Virginia 22030, United States; Recruiting

Additional Information

Starting date: March 2015
Last updated: June 3, 2015

Page last updated: August 23, 2015

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