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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care followed by Teduglutide | Experimental | Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure. |
|
| Teduglutide followed by Standard of Care | Experimental | Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | Daily 0.05 mg/kg Teduglutide administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average 3-day Fistula Percent Volume | Percent fistula volume will be reported from the participant | Baseline, Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ceased Fistula Output | As evaluated by treating physician of having at least 1 ceased fistula output | Up to 16 weeks |
| Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel D Yeh, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19707516 | Background | Jeppesen PB, Lund P, Gottschalck IB, Nielsen HB, Holst JJ, Mortensen J, Poulsen SS, Quistorff B, Mortensen PB. Short bowel patients treated for two years with glucagon-like Peptide 2: effects on intestinal morphology and absorption, renal function, bone and body composition, and muscle function. Gastroenterol Res Pract. 2009;2009:616054. doi: 10.1155/2009/616054. Epub 2009 Aug 20. | |
| 21317170 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Followed by Teduglutide | Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure. Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. |
| FG001 | Teduglutide Followed by Standard of Care | Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Followed by Teduglutide | Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure. Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Change in Average 3-day Fistula Percent Volume | Percent fistula volume will be reported from the participant | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Mean | Standard Deviation | Percent change in fistula volume | Baseline, Up to 8 weeks |
|
Up to 19 months
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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 | On Teduglutide | The study is a crossover design. All participants received 8 weeks of daily Teduglutide. Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. D. Dante Yeh | University of Miami | 3055851178 | dxy154@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2021 | Jun 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. |
|
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Social Functioning - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status.
| Up to 16 weeks |
| Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form | Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Sleep Impact - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status | Up to 16 weeks |
| Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health | Patient Reported Outcome Measures Information Systems Global Health has a total score ranging from 10-50 with the higher score indicating a healthier status | Up to 16 weeks |
| Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Belly Pain 5a questionnaire has a total score ranging from 1-25 with the lower score indicating a healthier status | Up to 16 weeks |
| Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Diarrhea 6a questionnaire has a total score ranging from 1-30 with the lower score indicating a healthier status | Up to 16 weeks |
| Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Nausea and Vomiting 4a questionnaire has a total score ranging from 1-20 with the lower score indicating a healthier status | Up to 16 weeks |
| Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a | Patient Reported Outcome Measures Information Systems (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 8a questionnaire has a total score ranging from 8-40 with the lower score indicating a healthier status | Up to 16 weeks |
| Background |
| 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. |
| 35871951 | Derived | Yeh DD, Vasileiou G, Abdul Jawad K, Pust GD, Byers PM. Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study. Clin Nutr ESPEN. 2022 Aug;50:49-55. doi: 10.1016/j.clnesp.2022.04.031. Epub 2022 May 12. |
| BG001 | Teduglutide Followed by Standard of Care | Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Ceased Fistula Output | As evaluated by treating physician of having at least 1 ceased fistula output | Ceased fistula output was reported for all participants at the end of treatment after receiving both interventions. | Posted | Count of Participants | Participants | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form | Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Social Functioning - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status. | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form | Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Sleep Impact - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health | Patient Reported Outcome Measures Information Systems Global Health has a total score ranging from 10-50 with the higher score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. 1 participant in the teduglutide arm did not complete the global health questionnaire. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Belly Pain 5a questionnaire has a total score ranging from 1-25 with the lower score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Diarrhea 6a questionnaire has a total score ranging from 1-30 with the lower score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a | Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Nausea and Vomiting 4a questionnaire has a total score ranging from 1-20 with the lower score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| Secondary | Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a | Patient Reported Outcome Measures Information Systems (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 8a questionnaire has a total score ranging from 8-40 with the lower score indicating a healthier status | This is a cross-over study. Each participant received both teduglutide intervention and the standard of care intervention for 8 weeks each. | Posted | Median | Standard Deviation | score on a scale | Up to 16 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | On Standard of Care | The study is a crossover design. All participants received 8 weeks of daily Standard of Care Therapy. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. | 0 | 6 | 0 | 6 | 2 | 6 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Stoma hypertrophy | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain at fistula site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Leg Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lip Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Right Sided Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Small Bleeding from Fistula | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| IV Infiltration | Surgical and medical procedures | Systematic Assessment |
|
| Increased Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Edema around ostomy site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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