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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

NCTNCT03663582 (opens ClinicalTrials.gov in a new tab)Other idSHP633-306
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
7 participants (actual)
Sponsor
Shire · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Japan

Start
6 Jul 2018
Primary completion
6 Aug 2019
Completion
6 Aug 2019
First posted
10 Sept 2018
Last update posted
4 Aug 2020
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 3

    Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

    NCT03663582

    6 Jul 2018 to 6 Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • TeduglutideDrug
  • SyringeDevice
  • NeedleDevice
  • Vial Adapter for DeviceDevice

Arms1

  • Experimental

    Teduglutide 0.05 mg

    Participants will receive teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.

Primary outcomes29

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    Change from baseline in weekly PS volume at EOT/ET was reported.

  2. 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)

    Registry description

    Percent change from baseline in weekly PS volume at EOT/ET was reported.

  3. 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

    Registry description

    Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported.

  4. 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

    Registry description

    Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported.

  5. 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)

    Registry description

    Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported.

  6. 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)

    Registry description

    Change from baseline in days per week of PS at EOT/ET was reported.

  7. Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported.

  8. Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT)

    Time frame · Week 24/EOT

    Registry description

    Number of participants who were completely weaned off PS at Week 24/EOT was reported.

  9. Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    AUC0-t of teduglutide was reported.

  10. Maximum Plasma Concentration (Cmax) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    Cmax of teduglutide was reported.

  11. Time to Maximum Plasma Concentration (Tmax) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    Tmax of teduglutide was reported.

  12. Terminal-phase Half-life (T1/2) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    T1/2 of teduglutide was reported.

  13. Apparent Clearance (CL/F) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    CL/F of teduglutide was reported.

  14. Apparent Volume of Distribution (Vz/F) of Teduglutide

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12

    Registry description

    Vz/F of teduglutide was reported.

  15. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame · From start of study drug administration up to EOT/ET (up to Week 28)

    Registry description

    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs whose onset occurred, severity worsened, or intensity increased after receiving the study medication.

  16. Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)

    Time frame · From start of study drug administration up to EOT/ET (up to Week 28)

    Registry description

    12-lead ECG was performed at the study center after the participant has been resting for at least 5 minutes. Number of participants with clinically significant abnormalities in 12-Lead ECG was reported.

  17. Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported.

  18. Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in pulse rate at EOT/ET was reported.

  19. Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in body temperature at EOT/ET was reported.

  20. Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in hemoglobin at EOT/ET was reported.

  21. Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in hematocrit at EOT/ET was reported.

  22. Change From Baseline in Serum Blood Urea Nitrogen (BUN) at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in serum blood urea nitrogen at EOT/ET was reported.

  23. Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in creatinine at EOT/ET was reported.

  24. Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in urine sodium at EOT/ET was reported.

  25. Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at End of Treatment/Early Termination (EOT/ET)

    Time frame · EOT/ET (up to Week 28)

    Registry description

    Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported.

  26. Change From Baseline in 48-Hour Urine Output at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in 48-hour urine output at EOT/ET was reported.

  27. Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in body weight at EOT/ET was reported.

  28. Change From Baseline in Body Mass Index (BMI) at End of Treatment/Early Termination (EOT/ET)

    Time frame · Baseline, EOT/ET (up to Week 28)

    Registry description

    Change from baseline in BMI at EOT/ET was reported.

  29. Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination)

    Time frame · Week 24/ET

    Registry description

    GI specific tests included colonoscopy or sigmoidoscopy, abdominal ultrasound, upper GI series with small bowel follow-through (UGI/SBFT). Number of participants with abnormal clinically significant changes in gastrointestinal specific tests at Week 24/ET was reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, EOT/ET (up to Week 28)

Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)

GroupValue (Liter per week (L/Week))Spread
Teduglutide-2.923.463
Primary outcomeMean· Baseline, EOT/ET (up to Week 28)

Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)

GroupValue (Percent change)Spread
Teduglutide-22.1924.953
Primary outcomeNumber· Baseline, Week 20

Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20

GroupValue (Percentage of participants)
Teduglutide66.7
Primary outcomeNumber· Baseline, Week 24

Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24

GroupValue (Percentage of participants)
Teduglutide66.7
Primary outcomeNumber· Baseline, EOT/ET (up to Week 28)

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)

GroupValue (Percentage of participants)
Teduglutide57.1
Primary outcomeMean· Baseline, EOT/ET (up to Week 28)

Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET)

GroupValue (Days per Week)Spread
Teduglutide-0.431.134
Primary outcomeMean· Baseline, EOT/ET (up to Week 28)

Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET)

GroupValue (Micromoles (mcmol))Spread
Teduglutide11.97311.7309
Primary outcomeCount of participants· Week 24/EOT

Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT)

GroupValue (Participants)
Teduglutide7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeduglutideParticipants received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.0 / 73 / 77 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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