Teduglutide for Enterocutaneous Fistula (ECF)

Daniel Dante Yeh

Status and phase: Completed; Phase 2

Conditions: Postoperative Fistula

Treatments: Other: Standard of Care; Drug: Teduglutide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02889393

20170189

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Standard of Care followed by Teduglutide

Experimental group

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.

Treatment:

Drug: Teduglutide

Other: Standard of Care

Teduglutide followed by Standard of Care

Experimental group

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

Treatment:

Drug: Teduglutide

Other: Standard of Care