Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
This trial is active, not recruiting.
|Condition||short bowel syndrome|
|Start date||March 2015|
|End date||March 2018|
|Trial size||11 participants|
|Trial identifier||NCT02340819, TED-C14-004|
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|
|Sendai, Japan||Tohoku University Hospital||no longer recruiting|
|Yokohama, Japan||Yokohama Municipal Citizen's Hospital||no longer recruiting|
|Hyogo, Japan||Hospital of Hyogo College of Medicine||no longer recruiting|
|Osaka, Japan||Osaka University Hospital, Department of Gastroenterological Surgery||no longer recruiting|
|Osaka, Japan||Osaka University Hospital, Department of Pediatric Surgery||no longer recruiting|
|Intervention model||single group assignment|
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
Absolute and percent change from baseline in weekly PN/I.V
time frame: 6 months treatment
time frame: Pre and Post Dose through 12 hours
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.
|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|
Call for more information