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Trial record 60 of 68 for:    tpn

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

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: NCT00930644
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : December 24, 2014
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Nycomed Germany GmbH
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 88
Recruitment Details Subjects who met any of the following could be enrolled: Completed 24 weeks of treatment in Study CL0600-020; based on PI and sponsor decision, subjects who were required to stop treatment prematurely due to a non drug related AE; or successfully completed Stage I (optimization/stabilization) in Study CL0600-020 after ~86 subjects were randomized
Pre-assignment Details  
Arm/Group Title Teduglutide 0.05 mg/kg/Day
Hide Arm/Group Description teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
Period Title: Overall Study
Started 88
Completed 65
Not Completed 23
Reason Not Completed
Withdrawal by Subject             4
Physician Decision             2
Death             1
Adverse Event             16
Arm/Group Title Teduglutide 0.05 mg/kg/Day
Hide Arm/Group Description teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
<=18 years
0
   0.0%
Between 18 and 65 years
73
  83.0%
>=65 years
15
  17.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
47
  53.4%
Male
41
  46.6%
Years since start of PN/IV dependecy  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
6.41  (6.272)
Prescribed weekly PN/IV volume  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 88 participants
12.07  (7.56)
Prescribed weekly number of days on PN/IV  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 88 participants
5.6  (1.68)
1.Primary Outcome
Title Percent Change in PN/IV Volume by Visit
Hide Description The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NT/TED PBO/TED TED/TED
Hide Arm/Group Description:
No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Overall Number of Participants Analyzed 12 39 37
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 -5.35  (11.287) -6.44  (11.241) -40.65  (21.546)
Month 2 -12.88  (22.789) -10.27  (14.027) -44.24  (21.823)
Month 3 -10.83  (47.396) -14.18  (16.440) -45.80  (22.681)
Month 6 -24.13  (17.496) -16.48  (20.979) -34.70  (55.319)
Month 9 -25.35  (17.855) -20.95  (27.500) -37.91  (57.460)
Month 12 -23.33  (20.296) -22.00  (33.858) -51.33  (28.299)
Month 15 -31.62  (25.901) -18.89  (33.165) -54.24  (27.871)
Month 18 -35.11  (35.545) -24.18  (32.183) -63.01  (26.587)
Month 21 -39.40  (36.504) -27.67  (33.064) -64.99  (27.920)
Month 24 -39.40  (36.504) -28.33  (35.169) -65.61  (33.606)
2.Primary Outcome
Title Absolute Change in PN/IV Volume by Visit
Hide Description The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NT/TED PBO/TED TED/TED
Hide Arm/Group Description:
No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Overall Number of Participants Analyzed 12 39 37
Mean (Standard Deviation)
Unit of Measure: Liters
Month 1 -1.05  (1.315) -0.95  (1.938) -5.28  (3.819)
Month 2 -1.88  (2.057) -1.38  (2.228) -5.62  (3.873)
Month 3 -2.55  (3.123) -1.65  (2.456) -5.72  (3.771)
Month 6 -3.85  (2.761) -1.90  (3.309) -5.20  (4.650)
Month 9 -3.69  (2.916) -2.61  (4.071) -5.59  (4.899)
Month 12 -2.90  (2.762) -2.72  (4.310) -6.36  (4.633)
Month 15 -3.58  (2.811) -2.48  (4.398) -6.37  (4.261)
Month 18 -3.63  (2.834) -2.90  (4.394) -6.99  (4.048)
Month 21 -4.01  (2.910) -3.00  (3.571) -7.34  (4.412)
Month 24 -4.01  (2.910) -3.11  (3.880) -7.55  (4.930)
3.Secondary Outcome
Title Number of Subjects Achieving PN/IV Reduction
Hide Description The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Time Frame 24 Months or Last Dosing Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NT/TED PBO/TED TED/TED
Hide Arm/Group Description:
No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
Overall Number of Participants Analyzed 12 39 37
Measure Type: Number
Unit of Measure: participants
Achieving >= 1 Day of PN/IV Reduction 3 14 21
Achieving >= 2 Day of PN/IV Reduction 2 7 18
Achieving >= 3 Day of PN/IV Reduction 2 5 18
Time Frame Adverse event data were collected for each subject from the time informed consent was signed to the end of the study. The most commonly reported treatment emergent adverse events (>= 3% grouped at PT level) are listed.
Adverse Event Reporting Description Adverse events monitoring was performed through investigator assessment and safety laboratory testing at each visit.
 
Arm/Group Title NT,PBO/TED TED/TED
Hide Arm/Group Description No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial 0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
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   32/51 (62.75%)      24/37 (64.86%)    
Blood and lymphatic system disorders     
Anaemia  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Lymphadenitis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Cardiac disorders     
Cardiac failure congestive  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Tachycardia  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Gastrointestinal disorders     
Crohns disease  1  1/51 (1.96%)  2 1/37 (2.70%)  1
Abdominal pain  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Abdominal pain upper  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Fecal volume increased  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Intestinal obstruction  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Melena  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Pancreatitis acute  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Papilla of Vater stenosis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
General disorders     
Pyrexia  1  4/51 (7.84%)  7 1/37 (2.70%)  1
Face oedema  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Injection site haematoma  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Soft tissue inflammation  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Cholecystitis acute  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Cholelithiasis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Cholestasis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Portal hypertension  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Infections and infestations     
Central line infection  1  3/51 (5.88%)  5 5/37 (13.51%)  7
Catheter bacteraemia  1  4/51 (7.84%)  7 0/37 (0.00%)  0
Catheter sepsis  1  3/51 (5.88%)  3 1/37 (2.70%)  1
Sepsis  1  3/51 (5.88%)  3 1/37 (2.70%)  1
Catheter related infection  1  1/51 (1.96%)  1 2/37 (5.41%)  2
Pneumonia  1  1/51 (1.96%)  1 2/37 (5.41%)  2
Urinary tract infection  1  0/51 (0.00%)  0 3/37 (8.11%)  4
Catheter site infection  1  0/51 (0.00%)  0 2/37 (5.41%)  3
Gastroenteritis  1  0/51 (0.00%)  0 2/37 (5.41%)  2
Bacteraemia  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Brain abscess  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Catheter site cellulitis  1  1/51 (1.96%)  2 0/37 (0.00%)  0
Clostridial infection  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Diverticulitis  1  0/51 (0.00%)  0 1/37 (2.70%)  2
Hepatic cyst infection  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Herpes Zoster  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Infection  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Intervertebral discitis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Sepsis syndrome  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Tuberculosis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Injury, poisoning and procedural complications     
Gastrointestinal stoma complication  1  2/51 (3.92%)  3 0/37 (0.00%)  0
Chemical burn of the eye  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Clavicle fracture  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Device breakage  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Incisional hernia  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Intestinal anastomosis complication  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Lumbar vertebral fracture  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Rib fracture  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Investigations     
Blood bilirubin increased  1  1/51 (1.96%)  1 1/37 (2.70%)  1
Alanine aminotransferase increased  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Aspartate aminotransferase increased  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Blood alkaline phosphatase increased  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Gamma glutamyltransferase increased  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalemia  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Lactic acidosis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung squamous cell carcinoma stage unspecified  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Metastatic neoplasm  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Non-small cell lung cancer  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/51 (0.00%)  0 1/37 (2.70%)  2
Syncope  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Suicide attempt  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Psychiatric disorders     
Delusional disorder, unspecified type  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Renal and urinary disorders     
Hydronephrosis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Nephrolithiasis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Renal colic  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Renal failure acute  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Renal failure chronic  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Dyspnoea  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Hydrothorax  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Pulmonary hypertension  1  1/51 (1.96%)  2 0/37 (0.00%)  0
Pulmonary oedema  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Vascular disorders     
Subclavian vein thrombosis  1  1/51 (1.96%)  1 1/37 (2.70%)  1
Deep vein thrombosis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Haematoma  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Hypertension  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Jugular vein thrombosis  1  1/51 (1.96%)  1 0/37 (0.00%)  0
Superior vena caval stenosis  1  0/51 (0.00%)  0 1/37 (2.70%)  1
Indicates events were collected by 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 3%
NT,PBO/TED TED/TED
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/51 (96.08%)      35/37 (94.59%)    
Blood and lymphatic system disorders     
Blood and Lymphatic System Disorders  1  5/51 (9.80%)  10 3/37 (8.11%)  5
Gastrointestinal disorders     
Gastrointestinal Disorders  1 [1]  34/51 (66.67%)  148 20/37 (54.05%)  68
General disorders     
General Disorders, and Administration Site Conditions  1  27/51 (52.94%)  100 15/37 (40.54%)  40
Hepatobiliary disorders     
Hepatobiliary Disorders  1  8/51 (15.69%)  10 2/37 (5.41%)  2
Infections and infestations     
Infections and Infestations  1  31/51 (60.78%)  97 26/37 (70.27%)  62
Injury, poisoning and procedural complications     
Injury, Poisoning, and Procedural Complications  1  19/51 (37.25%)  39 13/37 (35.14%)  39
Investigations     
Investigations  1  22/51 (43.14%)  62 19/37 (51.35%)  31
Metabolism and nutrition disorders     
Metabolism and Nutrition Disorder  1  14/51 (27.45%)  44 14/37 (37.84%)  33
Musculoskeletal and connective tissue disorders     
Musculoskeletal and Connective Tissue Disorders  1  11/51 (21.57%)  37 13/37 (35.14%)  23
Nervous system disorders     
Nervous System Disorders  1  10/51 (19.61%)  60 10/37 (27.03%)  18
Psychiatric disorders     
Psychiatric Disorders  1  8/51 (15.69%)  11 2/37 (5.41%)  2
Renal and urinary disorders     
Renal and Urinary Disorders  1  6/51 (11.76%)  17 4/37 (10.81%)  17
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic, and Mediastinal Disorders  1  10/51 (19.61%)  20 7/37 (18.92%)  9
Vascular disorders     
Vascular Disorder  1  14/51 (27.45%)  18 6/37 (16.22%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
Includes abdominal pain, nausea, abdominal distension, diarrhea, flatulence, vomiting, abdominal pain upper, dyspepsia, abdominal discomfort, constipation, faecal volume increased, intestinal obstruction, abdominal pain lower, and others.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of NPS Pharmaceuticals agreements with its investigators may vary. However, NPS does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e. data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Director, Clinical Development
Organization: NPS Pharmaceuticals
Phone: +1 908-450-5300
EMail: info@npsp.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00930644     History of Changes
Other Study ID Numbers: CL0600-021
First Submitted: June 26, 2009
First Posted: June 30, 2009
Results First Submitted: December 16, 2014
Results First Posted: December 24, 2014
Last Update Posted: December 8, 2015