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Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects (STEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00798967
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : February 1, 2012
Last Update Posted : June 3, 2021
Information provided by (Responsible Party):
Takeda ( Shire )

Brief Summary:
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: teduglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Actual Study Start Date : November 25, 2008
Actual Primary Completion Date : January 25, 2011
Actual Study Completion Date : January 25, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide

Arm Intervention/treatment
Experimental: Teduglutide
0.05 mg/kg/day sc dose of teduglutide
Drug: teduglutide
0.05 mg/kg/day sc injection for 24 weeks
Other Names:
  • ALX-0600

Placebo Comparator: Placebo
Matching subcutaneous dose of placebo to teduglutide
Drug: placebo
Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Primary Outcome Measures :
  1. Responder [ Time Frame: Weeks 20 and 24 ]
    Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.

Secondary Outcome Measures :
  1. Absolute Change in PN/I.V. Volume From Baseline to Last Time Point [ Time Frame: Week 0 to last visit when data was collected. ]
    Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed and dated informed consent prior to any study-related procedures are performed
  • Men and women 18 years of age or older at the time of informed consent signing
  • Intestinal failure resulting in Short Bowel Syndrome
  • At least 12 months of continuous PN dependency
  • 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
  • PN required at least 3 times weekly
  • A stable PN volume for four weeks prior to dosing

Exclusion Criteria:

  • History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • Participation in clinical study within 30 days for drug or 90 days for antibody
  • Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
  • Use of iv glutamine within 30 days prior to screening
  • Use of teduglutide
  • CD patients who have been treated with biological therapy within 6 months of screening
  • IBD patients who require chronic systemic immunosuppressant therapy
  • More than 4 SBS- or PN-related hospitalizations within 12 months of screening
  • Unplanned hospitalization within one month of screening
  • Pregnant or lactating women
  • Body weight > 88kg
  • Body mass index (BMI) < 15 kg/m2
  • Severe hepatic impairment or disturbed renal function
  • Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
  • Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
  • Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
  • Significant active, uncontrolled, untreated systemic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00798967

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Sponsors and Collaborators
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Study Director: Study Director Takeda
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Shire Identifier: NCT00798967    
Other Study ID Numbers: CL0600-020
2008-006193-15 ( EudraCT Number )
First Posted: November 27, 2008    Key Record Dates
Results First Posted: February 1, 2012
Last Update Posted: June 3, 2021
Last Verified: May 2021
Keywords provided by Takeda ( Shire ):
short bowel syndrome
parenteral nutrition
Additional relevant MeSH terms:
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Short Bowel Syndrome
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Gastrointestinal Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs