Teduglutide for Enterocutaneous Fistula (ECF)

Postoperative Fistula Clinical Trial

Official title:

Teduglutide for Treatment of Enterocutaneous Fistula (ECF) - a Pilot Study to Demonstrate Safety and Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889393
• Other study ID #: 20170189
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Intestinal Fistula
• Postoperative Fistula

Intervention

Drug:
• Teduglutide
Daily 0.05 mg/kg Teduglutide administered subcutaneously.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Dante Yeh	Takeda

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Average 3-day Fistula Percent Volume	Percent fistula volume will be reported from the participant	Baseline, Up to 8 weeks
Secondary	Number of Participants With Ceased Fistula Output	As evaluated by treating physician of having at least 1 ceased fistula output	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.	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	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	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	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	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	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	Up to 16 weeks