Teduglutide for Enterocutaneous Fistula (ECF)

Therapuetic Areas:Other
Age Range:18 - Any
Start Date:January 31, 2019
End Date:December 1, 2019
Contact:Daniel D Yeh, MD

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

The purpose of this study is to determine whether teduglutide is safe and feasible to be
given for the treatment of enterocutaneous fistula (ECF). We hypothesize 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.

Eligible patients will be initially randomly assigned to either daily subcutaneous
teduglutide injections (0.05 mg/kg/d) for 8 weeks or continued standard of care for 8 weeks.
After 8 weeks, the groups will cross over.

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

- 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
We found this trial at
Miami, Florida 33124
(305) 284-2211
Phone: 305-585-1822
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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