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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00308438
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease Intervention/treatment Phase
Crohn's 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.  

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 1, 2004
Primary Completion Date : November 1, 2005
Study Completion Date : June 1, 2006

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308438


  Show 24 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Bo Joelsson, MD NPS Pharma

Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00308438     History of Changes
Other Study ID Numbers: CL0600-009
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Shire:
Crohn Disease
Crohn's Disease

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