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||December 2014|
|End date||December 2017|
|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|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Male or female participants at least 16 years old.
Inclusion Criteria: 1. Men and women, 16 years of age or older at the time of signing the ICF 2. 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 3. For subjects with a history of Crohn's disease, the subject should be in clinical remission for at least 12 weeks prior to dosing as demonstrated by clinical assessment, which may include procedure-based evidence of remission. 4. 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 5. Stable PN/I.V. requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment, Exclusion Criteria: 1. Participation in a clinical study using an experimental drug within 30 days or an experimental antibody treatment within 3 months prior to signing the ICF, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide 2. Previous use of native GLP-2 or human growth hormone within 6 months prior to screening 3. Previous use of intravenous glutamine, octreotide, GLP-1 analog, or dipeptidyl peptidase-IV inhibitors within 30 days prior to screening 4. Previous use of teduglutide 5. Serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months 6. Subjects with active Crohn's disease or subjects who require biological therapy (eg, anti-tumor necrosis factor or natalizumab) that had been introduced or changed during the 6 months prior to screening 7. Subjects with inflammatory bowel disease who require chronic systemic immunosuppressant therapy that was introduced or changed during the last 3 months 8. Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome) 9. Radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome 10. Evidence of clinically significant obstruction on upper GI series with small bowel follow-through done within 6 months prior to screening 11. Major GI surgical intervention within 3 months prior to screening (insertion of feeding tube or endoscopic procedure is allowed) 12. Unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of subjects who had undergone ventricular or atrial septal defect repair 13. Currently diagnosed with cancer or a history of any cancer except basal cell carcinoma within 5 years 14. Active clinically significant pancreatic or biliary disease 15. More than 4 SBS-related or PN-related hospital admissions (eg, catheter sepsis, bowel obstruction, severe water-electrolyte disturbances) within 12 months prior to screening visit 16. Hospital admission, other than scheduled, within 30 days prior to screening 17. Signs of severe hepatic impairment at time of stabilization. 18. Signs of disturbed renal function at time of stabilization 19. Clinical signs of abnormal pancreatic condition, with abnormal laboratory results at time of stabilization 20. Pregnant or lactating women 21. Female subjects who are not surgically sterile or postmenopausal (defined as 55 years or older and/or at least 2 years had elapsed since her last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period 22. Not capable of understanding or not willing to adhere to the study visit schedule and other protocol requirements 23. Evidence of untreated intestinal obstruction or clinically significant active stenosis 24. Any condition or circumstance that in the investigator's opinion put the subject at any undue risk, prevented completion of the study, or interfered with analysis of the study results
|Official title||A 3-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|
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