Pilot Study to Investigate the Effect of Teduglutide on T... | NCT03953170

Studies
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

NCT03953170

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Status

Withdrawn

Last Update Posted

Feb 23, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Ileostomy - Stoma

Interventions

Teduglutide
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ended

Expanded Access Info

Start Date

Jun 2, 2022Actual

Primary Completion Date

Nov 25, 2022Actual

Completion Date

Dec 29, 2022Actual

First Submitted Date

Apr 15, 2019

First Submission Date that Met QC Criteria

May 14, 2019

First Posted Date

May 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Feb 23, 2023Actual

Name	Class
Shire	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.

Detailed Description

This is a prospective, controlled, randomized, double blind study. A total of 36 subjects will be enrolled into the study. Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed. Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh. The sites will be rotated with each injection. If adverse effects develop the subjects will be permitted to hold drug administration for a maximum of 5 days in total during the 12-week study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teduglutide	Active Comparator	Teduglutide 0.05 g/kg/day	Drug: Teduglutide
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teduglutide	Drug	Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only. The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA.

Measure	Description	Time Frame
Change in daily 24 hr ileostomy collection	(mL/day)	Change from time of surgery to 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care
Age- 18-80 years old
Normal routine laboratories (CMP, CBC, CRP, amylase, lipase)
Permitted medications will include biologicals which dose has not been changed for > 6 months, and immunosuppressant therapy which dose has not been changed for 3 months (i.e. codeine sulfate, loperamide, or Lomotil)

Exclusion Criteria:

Emergency need for ileostomy
Pregnant or nursing
Malnutrition or requiring parenteral or enteral nutrition
Known intestinal obstruction, stricture, or adhesions that would predispose the patient to the development of intestinal obstruction, perforation, hemorrhage, or intestinal abscess
Intestinal fistulas or abscess proximal to the ostomy
Small bowel resection greater than 50 cm.
Clinically significant cardiovascular, renal, pulmonary, endocrine, immunologic, dermatology, neurological or psychiatric disorders
Cholelithiasis or pancreatitis
Family history of colorectal cancer or familial polyposis
Cancer in the last 5 years
History of HIV, Hepatitis B or C, or other acute systemic or intestinal infections requiring antibiotics
Use of GLP1 analogues which may increase the risk of acute pancreatitis
Treatment of Octreotide

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
James McCormick, DO	Allegheny Health Network	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Allegheny General Hospital		Pittsburgh	Pennsylvania	15212	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C494910	teduglutide
C438272	ALX-0600

Masking Info

Masking

Triple

Masking Description

The drug will be delivered to the patient according to the randomization scheme and neither the patient nor the investigators will know which patient is randomized into which group until the study is completed. Only the pharmacist at the AHN pharmacy will know the patient assigned to each group.

Who Masked

ParticipantCare ProviderInvestigator