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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.
Information provided by (Responsible Party):
Shire Identifier:
First received: September 13, 2005
Last updated: November 10, 2015
Last verified: January 2015
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

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

Study Type: Interventional
Study Design: Intervention Model: Single Group 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:

Further study details as provided by Shire:

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 ]

Secondary Outcome Measures:
  • 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 ]
  • The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study [ Time Frame: 12 weeks after study start ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00308438

  Show 24 Study Locations
Sponsors and Collaborators
Study Director: Bo Joelsson, MD NPS Pharma
  More Information

Responsible Party: Shire Identifier: NCT00308438     History of Changes
Other Study ID Numbers: CL0600-009
Study First Received: September 13, 2005
Last Updated: November 10, 2015

Keywords provided by Shire:
Crohn Disease
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on May 25, 2017