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

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ClinicalTrials.gov Identifier: NCT00081458
Recruitment Status : Completed
First Posted : April 14, 2004
Results First Posted : July 15, 2013
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

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).

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Placebo Drug: Teduglutide 0.05 mg/kg/d Drug: Teduglutide 0.1 mg/kg/d Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Study Start Date : April 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide

Arm Intervention/treatment
Placebo Comparator: placebo
Placebo injectable subcutaneously daily into the thigh or abdomen
Drug: Placebo
placebo injectable subcutaneously daily into thigh or abdomen

Experimental: 2
teduglutide 0.05 mg/kg/d
Drug: Teduglutide 0.05 mg/kg/d
Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
Other Name: GATTEX

Experimental: 3
teduglutide 0.1 mg/kg/d
Drug: Teduglutide 0.1 mg/kg/d
Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
Other Name: GATTEX




Primary Outcome Measures :
  1. A Graded Response Score in Parenteral Nutrition (PN) Reduction [ Time Frame: 6 months ]

    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 :
  1. Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24 [ Time Frame: 6 months of treatment ]
    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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00081458


  Show 32 Study Locations
Sponsors and Collaborators
Shire
Investigators
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Study Director: Head Clinical Development NPS

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00081458     History of Changes
Other Study ID Numbers: CL0600-004
First Posted: April 14, 2004    Key Record Dates
Results First Posted: July 15, 2013
Last Update Posted: December 8, 2015
Last Verified: September 2014
Keywords provided by Shire:
Short Bowel Syndrome
Parenteral Nutrition
SBS
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Teduglutide
Gastrointestinal Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs