Overview

This trial is active, not recruiting.

Condition short bowel syndrome
Treatment teduglutide
Phase phase 3
Sponsor Shire
Start date March 2015
End date March 2018
Trial size 11 participants
Trial identifier NCT02340819, TED-C14-004

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
teduglutide
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.

Primary Outcomes

Measure
Absolute and percent change from baseline in weekly PN/I.V
time frame: 6 months treatment

Secondary Outcomes

Measure
Cmax (tmax)
time frame: Pre and Post Dose through 12 hours

Eligibility Criteria

All participants at least 16 years old.

Inclusion Criteria: - Men and women, 16 years of age or older at the time of signing the Informed Consent Form (ICF) - Subjects with SBS as a result of major intestinal resection (eg, due to injury, volvulus, vascular disease, cancer, Crohn's disease) that resulted in at least 12 continuous months of PN/I.V. dependency prior to signature of ICF. - For subjects with a hisotry of Crohn's disease, the subject should be in clinical remission for at least 12 weeks prior to dosing as demonstrated by clinical assessment. - PN/I.V. requirement of at least 3 times per week during the week before screening and during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs. - Stable PN/I.V. requirements for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. - Subjects who complete 24 weeks of dosing and still meeting the above criteria will continue into Stage 3 and Stage 4 of this study. Exclusion Criteria: - Participation in a clinical study using an experimental drug within 30 days or an experimental antibody treatment within 3 months prior to signing informed consent, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide. - Previous use of native GLP-2 or human growth hormone within 6 months prior to screening. - Previous use of intravenous glutamine, octreotide, GLP-1 analog, or dipeptidyl peptidase-IV inhibitors within 30 days prior to screening. - Previous us of teduglutide. - Serial transverse enteroplasty or any other bowel lengthening procedure performed within the past three months. - Subjects with active Crohn's disease or subjects who require biological therapy. - Subjects with inflammatory bowel disease who require chronic systemic immunosuppressant therapy that was introduced or changed during the last 3 months. - Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known DNA abnormalities (ie, Familial Adenomatons Polyposis, Fanconi syndrome). - Radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome. - Evidence of clinically significant obstruction on upper GI series with small bowel follow-through done within 6 months prior to screening. - Major GI surgical intervention within 3 months prior to screening. - Unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of subjects who had undergone ventricular or atrial septal defect repair. - Currently diagnosed with cancer or a history of any cancer except basal cell carcinoma within 5 years. - Active clinically significant pancreatic or biliary disease. - More than 4 SBS-related or PN-related hospital admissions within 12 months prior to screening visit. - Hospital admission, other than scheduled, within 30 days prior to screening. - Signs of severe hepatic impairment at time of stabilization. - Signs of disbturbed renal function at time of stabilization. - Clinical signs of abnormal pancreatic condition, with abnormal laboratory results at time time stabilization. - Pregnant or lactating women. - 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. - Evidence of untreated intestinal obstruction or clinically signficant active stenosis.

Additional Information

Official title A 4-Stage, Open-label, Multicenter Study Including Long-term Extension to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Shire.