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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01560403
First received: March 13, 2012
Last updated: November 10, 2015
Last verified: December 2014
History of Changes
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Short Bowel Syndrome
Intervention: Drug: Teduglutide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a 1-year, open-label, multi-center study in subjects who completed Study CL0600-021 (NCT00930644) at any US site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TED/TED This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
NT/PBO,TED This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly

Participant Flow:   Overall Study
    TED/TED   NT/PBO,TED
STARTED   5   9 
COMPLETED   5   8 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TED/TED This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
NT/PBO,TED This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
Total Total of all reporting groups

Baseline Measures
   TED/TED   NT/PBO,TED   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 5   9   14 
Age, Customized [1] 
[Units: Participants]
 		     
< 45 years   1   2   3 
45 - < 65 years   3   6   9 
>=65 years   1   1   2 
[1] Age at Study CL0600-020 (NCT00798967) Informed Consent (year)
Gender 
[Units: Participants]
 		     
Female   4   6   10 
Male   1   3   4 


  Outcome Measures

1.  Primary:   Summary of Treatment-emergent Adverse Events   [ Time Frame: 12 months ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study provided further long-term safety and efficacy data on the 14 US subjects who enrolled in the CL0600-020 and the CL0600-021 study. Given the small number of subjects in this study, only descriptive statistics were employed and presented.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Executive Director, Clinical Development
Organization: NPS Pharmaceuticals, Inc.
phone: 908-450-5300
e-mail: info@npsp.com



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01560403     History of Changes
Other Study ID Numbers: TED-C11-001
Study First Received: March 13, 2012
Results First Received: December 16, 2014
Last Updated: November 10, 2015