Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide; Syringe; Needle; Vial Adapter for Device
Intervention description: 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.; Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).; Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.; Vial adapter for device is approved for use in Japan by PMDA.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.