DRUG
Teduglutide
Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
Status
Completed
Phase
Phase 3
Enrollment
7
Locations
5
Results
Posted
Publications
0
Study summary
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous (PN/IV) over a 24-week treatment period.
Interventions
DRUG
Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
DEVICE
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).
DEVICE
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
DEVICE
Vial adapter for device is approved for use in Japan by PMDA.
Timeline
First posted
Sep 10, 2018
Study start
Jul 6, 2018
Primary completion
Aug 6, 2019
Study completion
Aug 6, 2019
Results posted
Aug 4, 2020
Registry updated
Aug 4, 2020
Outcomes
Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)
Time frame · Baseline, EOT/ET (up to Week 28)
Change from baseline in weekly PS volume at EOT/ET was reported.
Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)
Time frame · Baseline, EOT/ET (up to Week 28)
Percent change from baseline in weekly PS volume at EOT/ET was reported.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20
Time frame · Baseline, Week 20
Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame · Baseline, Week 24
Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported.
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET)
Time frame · Baseline, EOT/ET (up to Week 28)
Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported.
Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET)
Time frame · Baseline, EOT/ET (up to Week 28)
Change from baseline in days per week of PS at EOT/ET was reported.
Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET)
Time frame · Baseline, EOT/ET (up to Week 28)
Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported.
Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT)
Time frame · Week 24/EOT
Number of participants who were completely weaned off PS at Week 24/EOT was reported.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: 1. Ability to voluntarily provide written, signed, and informed consent to participate in the study. 2. Male or female 16 years of age or older at the time of signing informed consent. 3. Intestinal failure due to short bowel syndrome (SBS) as a result of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease) that resulted in at least 12 continuous months of parenteral nutrition/intravenous (PN/IV) dependence at the time of informed consent. 4. Parenteral nutrition requirement of at least 3 times per week during the week before the screening visit and during the 2 weeks prior to the baseline visit. 5. Stable PN/IV requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as: a. Actual PN/IV usage is similar to prescribed PN/IV; b. Baseline (Visit 2) 48-hour oral fluid intake and urine output (I/O) volumes fall within +/- 25 percent (%) of the respective 48-hour I/O volumes at the last optimization visit; c. Urine output volume should NOT fall below 2 liter (L) and should not exceed 4 L per 48 hours at the last optimization visit, the stabilization visit, and the baseline visit. 6. For participants with a history of Crohn's disease, clinical remission for at least 12 weeks prior to the baseline visit as demonstrated by clinical assessment, which may include procedure-based evidence of remission. 7. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. 8. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: 1. Participation in a clinical study using an experimental drug within 30 days or 5.5 halflives, whichever is longer, prior to screening, or concurrent participation in any other clinical study. 2. Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months. 3. Use of octreotide, GLP-1 analogs, dipeptidyl peptidase-IV inhibitors, or enteral glutamine within 30 days. 4. Previous use of teduglutide. 5. Participants with active inflammatory bowel disease (IBD) or participants with IBD who received a change in immunosuppressant therapy (example, azathioprine, anti- tumor necrosis factor (TNFs)) within the past 6 months. 6. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis, etc. 7. Chronic intestinal pseudo-obstruction or severe dysmotility. 8. Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (GI) series with small bowel follow-through, within the past 6 months. 9. Major GI surgical intervention, including bowel lengthening procedures, within the past 3 months (insertion of feeding tube or endoscopic procedure is allowed). 10. Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease). 11. Moderate or severe renal impairment, defined as creatinine clearance less than (\<) 50 millilitre (ml)/ minute (min). 12. Currently diagnosed with cancer or a history of any cancer except surgically curative skin cancer within the past 5 years. 13. Severe hepatobiliary disease including: a. Total bilirubin level greater than or equal to (\>=) 2 times the upper limit of normal (ULN); b. Aspartate aminotransferase (AST) \>=5 times ULN; c. Alanine aminotransferase (ALT) \>=5 times ULN. 14. Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase \>=2 times ULN. 15. More than 4 SBS-related or PN/IV-related hospital admissions (example, central line associated bloodstream infection, bowel obstruction, severe fluid/electrolyte disturbances) within the past 12 months. 16. Unscheduled hospitalization within 30 days prior to screening. 17. Pregnant or lactating female. 18. Any condition or circumstance that in the investigator's opinion put the participant at any undue risk, prevent completion of the study, or interfere with analysis of the study results.
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hyogo College of Medicine Hospital
Hyōgo, Japan
Tohoku University Hospital
Miyagi-Ken, Japan
Osaka University Hospital
Osaka, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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