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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

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

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

NCT ID

NCT02889393

First Posted

August 31, 2016

Last Updated

September 8, 2021

Sponsor

Daniel Dante Yeh

Collaborators

Takeda

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

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

Arm Title

Teduglutide followed by Standard of Care

Arm Type

Experimental

Arm Description

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

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

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

Time Frame

Up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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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