Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000439-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teduglutide 0.05 mg/kg/d | Experimental | 0.05 mg/kg/d teduglutide subcutaneous injection |
|
| teduglutide 0.10 mg/kg/d | Experimental | 0.10 mg/kg/d teduglutide subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teduglutide 0.05 mg/kg/d | Drug | 0.05 mg/kg/d subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving a 20% Reduction at Week 28 | For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use | Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No) | 6 months |
Not provided
Inclusion Criteria:
At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
Subjects who meet all of the following criteria can be enrolled in this study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21317170 | Result | Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11. | |
| 23333663 | Result |
Not provided
Not provided
This was a 28-week study of the safety and efficacy of teduglutide in subjects with parenteral nutrition-dependent short bowel syndrome who completed protocol CL0600-004
10Jan2005 - First Subject Enrolled 24Jan2008 - Last Subject Completed
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/0.05 | Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005 |
| FG001 | Placebo/0.10 | Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| teduglutide 0.10 mg/kg/d | Drug | 0.10 mg/kg/d subcutaneous injection |
|
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania - Penn Nursing | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z1Y6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G2N2 | Canada |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Hôpital Huriez | Lille | 59037 | France |
| Hôpital de la Croix-Rousse | Lyon | 69317 | France |
| Hôpital Lariboisière | Paris | 92110 | France |
| Academic Medical Center, Department of Endocrinology & Metabolism | Amsterdam | 1100 DD | Netherlands |
| Pracownia Żywienia | Olsztyn | 10-561 | Poland |
| Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP | Warsaw | 00-416 | Poland |
| St. Mark's Hospital | Harrow | HAI3UJ | United Kingdom |
| O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17. |
| 24134154 | Result | Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. |
| FG002 | 0.05/0.05 | Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005 |
| FG003 | 0.10/0.10 | Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/0.05 | Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005 |
| BG001 | Placebo/0.10 | Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005 |
| BG002 | 0.05/0.05 | Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005 |
| BG003 | 0.10/0.10 | Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Achieving a 20% Reduction at Week 28 | For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use. | Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures. | Posted | Number | Participants | 28 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use | Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No) | Response Status is Yes or No | Posted | Number | participants | 6 months |
|
28 weeks
Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/0.05 | Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005 | 2 | 6 | 6 | 6 | ||
| EG001 | Placebo/0.10 | Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005 | 3 | 7 | 7 | 7 | ||
| EG002 | 0.05/0.05 | Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005 | 13 | 25 | 22 | 25 | ||
| EG003 | 0.10/0.10 | Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005 | 9 | 27 | 26 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| GI haemorrhage | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter bacteremia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter bacteremia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
| |
| Intestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Reproductive system and breast Disorders | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorder | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (7.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|
| Participants |
|
|