Phase 3 N=86 Randomized Quadruple-blind Treatment

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

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00798967 ↗

Enrolled (actual)

Serious AEs

31.8%

Results posted

Feb 2012

Primary outcome: Primary: Responder — 27; 13 subjects — p=0.002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: teduglutide (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Responder	27; 13	0.002 sig
SECONDARY Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	-4.28; -2.38	< 0.001 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00798967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.