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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Teduglutide 0.05 mg/kg/d
Teduglutide 0.1 mg/kg/d
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Short Bowel Syndrome, Parenteral Nutrition, SBS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF) SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding Body weight must be less than 90 kg At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing Body mass index (BMI) 18 to 27 kg/m2 Adequate hepatic and renal function Exclusion Criteria: History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state History of alcohol or drug abuse (within previous year) Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study Clinically significant laboratory abnormalities at the time of randomization Previous use of teduglutide (ALX-0600) Prior use of native GLP-2 within 3 months of screening visit Hospital admission within 1 month prior to screening visit Pregnant or lactating women Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results. Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases

Sites / Locations

  • Mayo Clinic Scottsdale
  • Georgetown University
  • Emory University Hospital
  • Northwestern Center for Clinical Research
  • University of Kansas Medical Center
  • University of Nebraska Medical Center
  • Albany Medical Center
  • Mount Sinai School of Medicine
  • University of Rochester Medical Center
  • The Cleveland Clinic Foundation
  • University of Pennsylvania - Penn Nursing
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • l'Hôpital Erasme
  • Royal Alexandra Hospital
  • St. Paul's Hospital
  • St. Michael's Hospital
  • Toronto General Hospital
  • Rigshospitalet, University of Copenhagen
  • Hôpital Claude-Huriez
  • Hôpital de la Croix-Rousse
  • Hôpital Edouard Herriot
  • Hôpital Beaujon
  • Charité University Hospital
  • Charité-Universitätsmedizin Berlin
  • Universitätsklinikum Frankfurt
  • Academic Medical Center
  • Pracownia Żywienia Klinicznego
  • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
  • Hope Hospital
  • St. Mark's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

2

3

Arm Description

Placebo injectable subcutaneously daily into the thigh or abdomen

teduglutide 0.05 mg/kg/d

teduglutide 0.1 mg/kg/d

Outcomes

Primary Outcome Measures

A Graded Response Score in Parenteral Nutrition (PN) Reduction
The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20.

Secondary Outcome Measures

Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24
An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.

Full Information

First Posted
April 13, 2004
Last Updated
May 24, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00081458
Brief Title
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
Official Title
A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2004 (Actual)
Primary Completion Date
July 6, 2007 (Actual)
Study Completion Date
July 6, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
Detailed Description
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines. The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Short Bowel Syndrome, Parenteral Nutrition, SBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injectable subcutaneously daily into the thigh or abdomen
Arm Title
2
Arm Type
Experimental
Arm Description
teduglutide 0.05 mg/kg/d
Arm Title
3
Arm Type
Experimental
Arm Description
teduglutide 0.1 mg/kg/d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo injectable subcutaneously daily into thigh or abdomen
Intervention Type
Drug
Intervention Name(s)
Teduglutide 0.05 mg/kg/d
Other Intervention Name(s)
GATTEX
Intervention Description
Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
Intervention Type
Drug
Intervention Name(s)
Teduglutide 0.1 mg/kg/d
Other Intervention Name(s)
GATTEX
Intervention Description
Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
Primary Outcome Measure Information:
Title
A Graded Response Score in Parenteral Nutrition (PN) Reduction
Description
The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24
Description
An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.
Time Frame
6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF) SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding Body weight must be less than 90 kg At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing Body mass index (BMI) 18 to 27 kg/m2 Adequate hepatic and renal function Exclusion Criteria: History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state History of alcohol or drug abuse (within previous year) Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study Clinically significant laboratory abnormalities at the time of randomization Previous use of teduglutide (ALX-0600) Prior use of native GLP-2 within 3 months of screening visit Hospital admission within 1 month prior to screening visit Pregnant or lactating women Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results. Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania - Penn Nursing
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
l'Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2N2
Country
Canada
Facility Name
Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital Claude-Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital Beaujon
City
Paris
ZIP/Postal Code
92110
Country
France
Facility Name
Charité University Hospital
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Pracownia Żywienia Klinicznego
City
Olsztyn
ZIP/Postal Code
10-651
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
City
Warsaw
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Hope Hospital
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M68HD
Country
United Kingdom
Facility Name
St. Mark's Hospital
City
Harrow
ZIP/Postal Code
HA13UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
1904648
Citation
Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. doi: 10.1016/s0039-6109(16)45438-1.
Results Reference
background
PubMed Identifier
3109044
Citation
Rombeau JL, Rolandelli RH. Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome. Surg Clin North Am. 1987 Jun;67(3):551-71. doi: 10.1016/s0039-6109(16)44232-5.
Results Reference
background
PubMed Identifier
8205419
Citation
Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. doi: 10.1002/bjs.1800810404.
Results Reference
background
PubMed Identifier
9352883
Citation
Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. doi: 10.1053/gast.1997.v113.pm9352883.
Results Reference
background
PubMed Identifier
21317170
Citation
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.
Results Reference
result
PubMed Identifier
27507402
Citation
Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.
Results Reference
derived

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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

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