This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
0.05 mg/kg/day subcutaneously taken once per day for 12 months
Scripps Clinic & Research Foundation
La Jolla, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Mount Sinai Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Summary of Treatment-emergent Adverse Events
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Time frame: 12 months
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Vanderbilt University Medical Center
Nashville, Tennessee, United States