Text Size

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

This study has been completed.
Sponsor:
Information provided by:
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00308438
First received: September 13, 2005
Last updated: August 11, 2008
Last verified: August 2008
History of Changes

September 13, 2005
August 11, 2008
March 2004
November 2005   (final data collection date for primary outcome measure)
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 ]
The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
Complete list of historical versions of study NCT00308438 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
  • The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study
Not Provided
Not Provided
 
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
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 purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
Drug: Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Other Name: teduglutide
Experimental: 1
All subjects in the study dosed at 0.1 mg/kg teduglutide
Intervention: Drug: Teduglutide (ALX-0600)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
June 2006
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have completed participation in the Pilot Active Crohn's Disease Study.

  • Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

    • CDAI score greater than 220
    • Stool samples not required
    • C-reactive protein levels are not an exclusion criterion

Exclusion Criteria:

  • Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

    • Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00308438
CL0600-009
No
Director of Clinical Operations, NPS Pharmaceuticals
NPS Pharmaceuticals
Not Provided
Study Director: David Jacobs, MD NPS Pharmaceuticals
NPS Pharmaceuticals
August 2008

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