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This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide | Experimental | 0.05 mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | 0.05 mg/kg/day subcutaneously taken once per day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Treatment-emergent Adverse Events | 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. | 12 months |
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Inclusion Criteria:
At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic & Research Foundation | La Jolla | California | 92037 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29761915 | Result | Seidner DL, Fujioka K, Boullata JI, Iyer K, Lee HM, Ziegler TR. Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study. Nutr Clin Pract. 2018 Aug;33(4):520-527. doi: 10.1002/ncp.10092. Epub 2018 May 15. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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This was a 1-year, open-label, multi-center study in subjects who completed Study CL0600-021 (NCT00930644) at any US site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | NT/PBO,TED |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age at Study CL0600-020 (NCT00798967) Informed Consent (year) |
| 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 | Summary of Treatment-emergent Adverse Events | 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. | Safety Population | Posted | Number | participants | 12 months |
|
1 year, 2 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenic conditions | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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). |
|
|
| 1 |
| 9 |
| 4 |
| 9 |
| EG001 | 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) | 5 | 5 | 4 | 5 |
| Atrial tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Central line infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anxiety symptoms | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Benign neoplasms gastrointestinal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Catheter site related reaction | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Cognition and attention disorders and disturbances | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
|
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |