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Teduglutide for Enterocutaneous Fistula (ECF)

Primary Purpose

Postoperative Fistula

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Teduglutide
Standard of Care
Sponsored by
Daniel Dante Yeh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18
  • Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia

Exclusion Criteria:

  • Perianal fistula
  • Clinical suspicion of inflammatory bowel disease
  • History of radiation enteritis or sprue (as defined by history)
  • Active (<1 year) alcohol or drug abuse
  • Significant hepatic, or cardiac diseases as defined as:
  • Hepatic: aspartate aminotransferase (AST) > 2 times upper limit of normal (10-40 U/L)
  • Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
  • Severe renal dysfunction: serum creatinine > 2 times upper limit of normal (0.6-1.5 mg/dL)
  • Received glutamine less than 4 weeks prior to screening
  • Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
  • Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
  • Active malignancy or suspicion for gastrointestinal malignancy on CT scan
  • Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
  • Family history of intestinal malignancy (gastric, small intestine, colon)
  • Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
  • Positive hemoccult (per rectum)
  • Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
  • Taking oral benzodiazepines, barbiturates, or phenothiazines

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of Care followed by Teduglutide

Teduglutide followed by Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Average 3-day Fistula Percent Volume
Percent fistula volume will be reported from the participant

Secondary Outcome Measures

Number of Participants With Ceased Fistula Output
As evaluated by treating physician of having at least 1 ceased fistula output
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.
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
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
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
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
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
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

Full Information

First Posted
August 31, 2016
Last Updated
September 8, 2021
Sponsor
Daniel Dante Yeh
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02889393
Brief Title
Teduglutide for Enterocutaneous Fistula (ECF)
Official Title
Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Dante Yeh
Collaborators
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care followed by Teduglutide
Arm Type
Experimental
Arm Description
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.
Arm Title
Teduglutide followed by Standard of Care
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Teduglutide
Other Intervention Name(s)
Gattex
Intervention Description
Daily 0.05 mg/kg Teduglutide administered subcutaneously.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Average 3-day Fistula Percent Volume
Description
Percent fistula volume will be reported from the participant
Time Frame
Baseline, Up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Ceased Fistula Output
Description
As evaluated by treating physician of having at least 1 ceased fistula output
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form
Description
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.
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form
Description
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
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health
Description
Patient Reported Outcome Measures Information Systems Global Health has a total score ranging from 10-50 with the higher score indicating a healthier status
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a
Description
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
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a
Description
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
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a
Description
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
Time Frame
Up to 16 weeks
Title
Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a
Description
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
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia Exclusion Criteria: Perianal fistula Clinical suspicion of inflammatory bowel disease History of radiation enteritis or sprue (as defined by history) Active (<1 year) alcohol or drug abuse Significant hepatic, or cardiac diseases as defined as: Hepatic: aspartate aminotransferase (AST) > 2 times upper limit of normal (10-40 U/L) Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion) Severe renal dysfunction: serum creatinine > 2 times upper limit of normal (0.6-1.5 mg/dL) Received glutamine less than 4 weeks prior to screening Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone) Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD)) Active malignancy or suspicion for gastrointestinal malignancy on CT scan Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements Family history of intestinal malignancy (gastric, small intestine, colon) Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer Positive hemoccult (per rectum) Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease Taking oral benzodiazepines, barbiturates, or phenothiazines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel D Yeh, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19707516
Citation
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.
Results Reference
background
PubMed Identifier
21317170
Citation
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.
Results Reference
background
PubMed Identifier
35871951
Citation
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.
Results Reference
derived

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Teduglutide for Enterocutaneous Fistula (ECF)

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