Teduglutide for Enterocutaneous Fistula (ECF)

Phase 2

Completed

Conditions: Postoperative Fistula

Interventions: Drug: Teduglutide
Other: Standard of Care

Registration Number: NCT02889393

Lead Sponsor: Daniel Dante Yeh

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care followed by Teduglutide	Teduglutide	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.
Standard of Care followed by Teduglutide	Standard of Care	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.
Teduglutide followed by Standard of Care	Standard of Care	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
Teduglutide followed by Standard of Care	Teduglutide	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

Primary Outcome Measures

Name	Time	Method
Change in Average 3-day Fistula Percent Volume	Baseline, Up to 8 weeks	Percent fistula volume will be reported from the participant

Secondary Outcome Measures

Name	Time	Method
Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health	Up to 16 weeks	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	Up to 16 weeks	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	Up to 16 weeks	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	Up to 16 weeks	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	Up to 16 weeks	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
Number of Participants With Ceased Fistula Output	Up to 16 weeks	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	Up to 16 weeks	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	Up to 16 weeks	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