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出境医 / 临床实验 / Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Drug: Teduglutide Drug: Placebo Phase 3

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Masking: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Teduglutide
Teduglutide 0.05 g/kg/day
 Drug: Teduglutide

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.

Other Name: Gattex
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Outcome Measures
Primary Outcome Measures :
  1. Change in daily 24 hr ileostomy collection [ Time Frame: Change from time of surgery to 12 weeks ]
    (mL/day)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Jorge A Vazquez, MD 412-359-3095 jorge.vazquez@ahn.org

Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Shire
Investigators
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Principal Investigator: Jorge A Vazquez, MD Allegheny Health Network
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date March 17, 2021
Estimated Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Change in daily 24 hr ileostomy collection [ Time Frame: Change from time of surgery to 12 weeks ]
(mL/day)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Official Title  ICMJE Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Masking: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Condition  ICMJE Ileostomy - Stoma
Intervention  ICMJE
  • Drug: Teduglutide

    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.

    Other Name: Gattex
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Teduglutide
    Teduglutide 0.05 g/kg/day
    Intervention: Drug: Teduglutide
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jorge A Vazquez, MD 412-359-3095 jorge.vazquez@ahn.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953170
Other Study ID Numbers  ICMJE Teduglutide
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)
Responsible Party Jorge Vazquez, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study Sponsor  ICMJE Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators  ICMJE Shire
Investigators  ICMJE
Principal Investigator: Jorge A Vazquez, MD Allegheny Health Network
PRS Account Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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