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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
teduglutide 0.05 mg/kg/d
teduglutide 0.10 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, Teduglutide

Eligibility Criteria

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

Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed Completion of protocol CL0600-004 (NCT00081458) 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) Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of 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

Sites / Locations

  • Mayo Clinic Scottsdale
  • Emory University Hospital
  • University of Nebraska Medical Center
  • Albany Medical Center
  • University of Rochester Medical Center
  • The Cleveland Clinic Foundation
  • University of Pennsylvania - Penn Nursing
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • Hôpital Erasme
  • St. Paul's Hospital
  • St. Michael's Hospital
  • Toronto General Hospital
  • Rigshospitalet
  • Hôpital Huriez
  • Hôpital de la Croix-Rousse
  • Hôpital Lariboisière
  • Academic Medical Center, Department of Endocrinology & Metabolism
  • Pracownia Żywienia
  • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
  • St. Mark's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

teduglutide 0.05 mg/kg/d

teduglutide 0.10 mg/kg/d

Arm Description

0.05 mg/kg/d teduglutide subcutaneous injection

0.10 mg/kg/d teduglutide subcutaneous injection

Outcomes

Primary Outcome Measures

Number of Subjects Achieving a 20% Reduction at Week 28
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.

Secondary Outcome Measures

Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)

Full Information

First Posted
September 13, 2005
Last Updated
May 12, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00172185
Brief Title
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Official Title
A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2005 (Actual)
Primary Completion Date
January 24, 2008 (Actual)
Study Completion Date
January 24, 2008 (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 clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Detailed Description
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

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, Teduglutide

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
teduglutide 0.05 mg/kg/d
Arm Type
Experimental
Arm Description
0.05 mg/kg/d teduglutide subcutaneous injection
Arm Title
teduglutide 0.10 mg/kg/d
Arm Type
Experimental
Arm Description
0.10 mg/kg/d teduglutide subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
teduglutide 0.05 mg/kg/d
Other Intervention Name(s)
GATTEX
Intervention Description
0.05 mg/kg/d subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
teduglutide 0.10 mg/kg/d
Other Intervention Name(s)
GATTEX
Intervention Description
0.10 mg/kg/d subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Subjects Achieving a 20% Reduction at Week 28
Description
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Description
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed Completion of protocol CL0600-004 (NCT00081458) 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) Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of 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
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
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
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
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
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
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital 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 Lariboisière
City
Paris
ZIP/Postal Code
92110
Country
France
Facility Name
Academic Medical Center, Department of Endocrinology & Metabolism
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Pracownia Żywienia
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
City
Warsaw
ZIP/Postal Code
00-416
Country
Poland
Facility Name
St. Mark's Hospital
City
Harrow
ZIP/Postal Code
HAI3UJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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
23333663
Citation
O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.
Results Reference
result
PubMed Identifier
24134154
Citation
Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.
Results Reference
result

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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

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