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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
  Purpose

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.


Condition Intervention Phase
Crohn Disease
 Drug: Teduglutide (ALX-0600)
 Phase 2

NPS Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Teduglutide
U.S. FDA Resources

Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 67
Study Start Date: March 2004
Study Completion Date: June 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308438

  Show 24 Study Locations
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: David Jacobs, MD NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: Director of Clinical Operations, NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00308438     History of Changes
Other Study ID Numbers: CL0600-009
Study First Received: September 13, 2005
Last Updated: August 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Crohn Disease
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013