Phase 2
N=6
Teduglutide for Enterocutaneous Fistula (ECF)
Postoperative Fistula
Bottom Line
View on ClinicalTrials.gov: NCT02889393 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Average 3-day Fistula Percent Volume — 76.33; 441.67 Percent change in fistula volume
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Teduglutide (Drug); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daniel Dante Yeh
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average 3-day Fistula Percent Volume |
76.33; 441.67 | — |
| SECONDARY Number of Participants With Ceased Fistula Output |
3 | — |
| SECONDARY Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form |
20.5; 20 | — |
| SECONDARY Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form |
19.5; 19.5 | — |
| SECONDARY Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health |
30; 35 | — |
| SECONDARY Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a |
6.0; 7.5 | — |
| SECONDARY Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a |
8.0; 6.0 | — |
| SECONDARY Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a |
3.0; 3.5 | — |
| SECONDARY Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a |
32.0; 34.0 | — |
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.
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02889393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.