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Trial record 57 of 68 for:    tpn

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

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: NCT01560403
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : December 25, 2014
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Short Bowel Syndrome
Intervention Drug: Teduglutide
Enrollment 14
Recruitment Details 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  
Arm/Group Title TED/TED NT/PBO,TED
Hide Arm/Group Description 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) 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
Period Title: Overall Study
Started 5 9
Completed 5 8
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title TED/TED NT/PBO,TED Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 5 9 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 9 participants 14 participants
< 45 years 1 2 3
45 - < 65 years 3 6 9
>=65 years 1 1 2
[1]
Measure Description: Age at Study CL0600-020 (NCT00798967) Informed Consent (year)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 9 participants 14 participants
Female
4
  80.0%
6
  66.7%
10
  71.4%
Male
1
  20.0%
3
  33.3%
4
  28.6%
1.Primary Outcome
Title Summary of Treatment-emergent Adverse Events
Hide Description As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title NT,PBO/TED TED/TED
Hide Arm/Group Description:
This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) 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.
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).
Overall Number of Participants Analyzed 9 5
Measure Type: Number
Unit of Measure: participants
4 5
Time Frame 1 year, 2 months
Adverse Event Reporting Description

Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013.

Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.

 
Arm/Group Title NT/PBO,TED TED/TED
Hide Arm/Group Description 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 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)
All-Cause Mortality
NT/PBO,TED TED/TED
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NT/PBO,TED TED/TED
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      5/5 (100.00%)    
Cardiac disorders     
Atrial fibrillation * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Atrial tachycardia * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Cardiac failure acute * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Cardiac failure congestive * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Cardiomyopathy * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Ischaemic cardiomyopathy * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations     
Central line infection * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Pneumonia * 1  0/9 (0.00%)  0 1/5 (20.00%)  2
Urinary tract infection * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
In-stent arterial restenosis * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Upper limb fracture * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Lactic acidosis * 1  1/9 (11.11%)  1 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/9 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NT/PBO,TED TED/TED
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      4/5 (80.00%)    
Gastrointestinal disorders     
Diarrhoea * 1  1/9 (11.11%)  1 2/5 (40.00%)  3
Abdominal pain * 1  2/9 (22.22%)  2 0/5 (0.00%)  0
General disorders     
Asthenic conditions * 1  2/9 (22.22%)  2 1/5 (20.00%)  1
Immune system disorders     
Hypersensitivity * 1  2/9 (22.22%)  2 0/5 (0.00%)  0
Seasonal allergy * 1  1/9 (11.11%)  1 1/5 (20.00%)  1
Infections and infestations     
Catheter sepsis * 1  0/9 (0.00%)  0 2/5 (40.00%)  2
Lower respiratory tract infection * 1  1/9 (11.11%)  1 1/5 (20.00%)  2
Upper respiratory tract infection * 1  1/9 (11.11%)  1 1/5 (20.00%)  1
Viral infection * 1  2/9 (22.22%)  2 0/5 (0.00%)  0
Injury, poisoning and procedural complications     
Catheter site related reaction * 1  1/9 (11.11%)  2 1/5 (20.00%)  1
Investigations     
Hepatic enzyme increased * 1  1/9 (11.11%)  3 1/5 (20.00%)  1
Weight decreased * 1  0/9 (0.00%)  0 2/5 (40.00%)  3
Metabolism and nutrition disorders     
Fluid overload * 1  1/9 (11.11%)  2 1/5 (20.00%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain * 1  1/9 (11.11%)  1 1/5 (20.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign neoplasms gastrointestinal * 1  2/9 (22.22%)  2 0/5 (0.00%)  0
Psychiatric disorders     
Anxiety symptoms * 1  1/9 (11.11%)  1 1/5 (20.00%)  1
Cognition and attention disorders and disturbances * 1  2/9 (22.22%)  3 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/9 (0.00%)  0 2/5 (40.00%)  2
Vascular disorders     
Hypertension * 1  1/9 (11.11%)  1 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01560403     History of Changes
Other Study ID Numbers: TED-C11-001
First Submitted: March 13, 2012
First Posted: March 22, 2012
Results First Submitted: December 16, 2014
Results First Posted: December 25, 2014
Last Update Posted: June 4, 2019