Teduglutide for Enterocutaneous Fistula (ECF)

NCT02889393 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20170189
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Fistula

Outcome Measures

Primary Outcomes (1)

• Change in Average 3-day Fistula Percent Volume

  Percent fistula volume will be reported from the participant

  Baseline, Up to 8 weeks

Secondary Outcomes (8)

• Number of Participants With Ceased Fistula Output

  Up to 16 weeks

• Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form

  Up to 16 weeks

• Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form

  Up to 16 weeks

• Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health

  Up to 16 weeks

• Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a

  Up to 16 weeks

Study Arms (2)

Standard of Care followed by Teduglutide

EXPERIMENTAL

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.

Drug: Teduglutide; Other: Standard of Care

Teduglutide followed by Standard of Care

EXPERIMENTAL

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

Drug: Teduglutide; Other: Standard of Care

Interventions

Teduglutide DRUG

Daily 0.05 mg/kg Teduglutide administered subcutaneously.

Also known as: Gattex

Standard of Care followed by Teduglutide; Teduglutide followed by Standard of Care

Standard of Care OTHER

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.

Standard of Care followed by Teduglutide; Teduglutide followed by Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Dante Yeh: lead
• Takeda: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (3)

• 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.

  PMID: 19707516 BACKGROUND

• 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.

  PMID: 21317170 BACKGROUND

• Yeh DD, Vasileiou G, Abdul Jawad K, Pust GD, Byers PM. Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study. Clin Nutr ESPEN. 2022 Aug;50:49-55. doi: 10.1016/j.clnesp.2022.04.031. Epub 2022 May 12.

  PMID: 35871951 DERIVED

MeSH Terms

Interventions

teduglutide; ALX-0600; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. D. Dante Yeh
• Organization: University of Miami

dxy154@med.miami.edu

3055851178

Study Officials

• Daniel D Yeh, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: January 31, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2021
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)