Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
NPS Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008|
- The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. [ Time Frame: 12 weeks after start of study ] [ Designated as safety issue: No ]
- Secondary Outcomes:
- The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved. [ Time Frame: 12 weeks after study start ] [ Designated as safety issue: No ]
- The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
|Study Start Date:||March 2004|
|Study Completion Date:||June 2006|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
All subjects in the study dosed at 0.1 mg/kg teduglutide
Drug: Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Other Name: teduglutide
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308438
Show 24 Study Locations
|Study Director:||David Jacobs, MD||NPS Pharmaceuticals|