Open Label Long-term Safety Study of AT1001 in Patients With Fabry Disease Who Have Completed a Previous AT1001 Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amicus Therapeutics
ClinicalTrials.gov Identifier:
NCT00526071
First received: September 5, 2007
Last updated: December 19, 2013
Last verified: December 2013

September 5, 2007
December 19, 2013
September 2007
October 2012   (final data collection date for primary outcome measure)
Long term safety and outcomes measures assessed at each visit. [ Time Frame: Long term ] [ Designated as safety issue: Yes ]
Long term safety and outcomes measures assessed at each visit. [ Time Frame: long term ]
Complete list of historical versions of study NCT00526071 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open Label Long-term Safety Study of AT1001 in Patients With Fabry Disease Who Have Completed a Previous AT1001 Study
Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of AT1001 in Patients With Fabry Disease

This is a long term open label study of AT1001 in patients with Fabry disease previously enrolled in a Phase 2 AT1001 trial.

This is a long term open label study of AT1001 in patients with Fabry disease previously enrolled in a Phase 2 AT1001 trial. Patients will return to the study center approximately every 3 months for safety evaluations including physical exam, blood and urine tests.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fabry Disease
Drug: AT1001
AT1001
Experimental: 1
AT1001 dose group 1
Intervention: Drug: AT1001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Must have completed another Phase 2 trial of AT1001 in Fabry Disease
  2. Women of childbearing potential must have negative pregnancy result
  3. Male and Female subjects agree to use reliable method of contraception during treatment and four weeks after treatment has completed.
  4. Subject is willing and able to provide written informed consent

Exclusion Criteria:

  1. Subject did not complete Phase 2 trial of AT1001 in Fabry Disease
  2. Has undergone or is scheduled to undergo kidney transplantation or is currently on dialysis
  3. Has been treated with another investigational drug (except AT1001) within 30 days of study start
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   France,   United Kingdom
 
NCT00526071
FAB-CL-205
No
Amicus Therapeutics
Amicus Therapeutics
Not Provided
Study Director: Medical Director Amicus Therapeutics
Amicus Therapeutics
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP