Study Complete
Sponsor ID
HPN-100-011
To evaluate the safety of long-term use of HPN-100 in the management of urea cycle disorders (UCDs)
Study Details
This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover studies, and their associated safety extensions were 12-month, open-label studies. All participants who completed the initial studies were eligible to enroll in the associated safety extension studies, and new participants were also permitted to enroll directly into the safety extension studies.
Protocol Summary
Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available
Locations
Location
Children's National Medical Center
Washington, DC, United States, 20010
Status
Completed
Location
Mount Sinai School of Medicine
New York, NY, United States, 10029
Status
Completed
Location
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Status
Completed
Location
University of Minnesota Medical Center
Minneapolis, MN, United States, 55454
Status
Completed
Location
Children's Hospital of Wisconsin
Milwaukee, WI, United States, 53226
Status
Completed
Location
Seattle Children's Hospital
Seattle, WA, United States, 98105
Status
Completed
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