Short Bowel SyndromePhase 3NCT03663582

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

A Phase 3 study testing Teduglutide, Syringe and Needle in people with Short Bowel Syndrome, run by Shire at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Teduglutide, Syringe and Needle
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 5 sitesJapan
Study dates: 6 Jul 2018to 6 Aug 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Ability to voluntarily provide written, signed, and informed consent to participate in the study.
Male or female 16 years of age or older at the time of signing informed consent.
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.
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.
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.
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.
Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Who cannot join

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.
Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months.
Use of octreotide, GLP-1 analogs, dipeptidyl peptidase-IV inhibitors, or enteral glutamine within 30 days.
Previous use of teduglutide.
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.
Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis, etc.

Show all 18Show fewer

Chronic intestinal pseudo-obstruction or severe dysmotility.
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.
Major GI surgical intervention, including bowel lengthening procedures, within the past 3 months (insertion of feeding tube or endoscopic procedure is allowed).
Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease).
Moderate or severe renal impairment, defined as creatinine clearance less than (<) 50 millilitre (ml)/ minute (min).
Currently diagnosed with cancer or a history of any cancer except surgically curative skin cancer within the past 5 years.
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.
Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase >=2 times ULN.
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.
Unscheduled hospitalization within 30 days prior to screening.
Pregnant or lactating female.
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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Hyogo College of Medicine Hospital
Hyōgo, 663-8501
Tohoku University Hospital
Miyagi-Ken, 980-8574
Osaka University Hospital
Osaka, 565-0871
Yokohama Municipal Citizen's Hospital
Yokohama, 240-8555

Other trials in Japan

About this study

Official title: A 24-Week Safety, Efficacy, Pharmacokinetic Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Conditions: Short Bowel Syndrome
Being tested: Teduglutide, Syringe, Needle, Vial Adapter for Device
Medical subject headings: Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeduglutideDrug
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.
SyringeDevice
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).
NeedleDevice
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Vial Adapter for DeviceDevice
Vial adapter for device is approved for use in Japan by PMDA.

Study groups in NCT03663582
Study group	Role	What they receive
Teduglutide 0.05 mg	Experimental	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. Receives: Drug: Teduglutide; Device: Syringe; Device: Needle; Device: Vial Adapter for Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET)
Change from baseline in weekly PS volume at EOT/ET was reported.
Measured: 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)
Percent change from baseline in weekly PS volume at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20
Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported.
Measured: Baseline, Week 20
Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported.
Measured: Baseline, Week 24
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)
Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported.
Measured: 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)
Change from baseline in days per week of PS at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET)
Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT)
Number of participants who were completely weaned off PS at Week 24/EOT was reported.
Measured: Week 24/EOT
Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide
AUC0-t of teduglutide was reported.
Measured: 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
Maximum Plasma Concentration (Cmax) of Teduglutide
Cmax of teduglutide was reported.
Measured: 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
Time to Maximum Plasma Concentration (Tmax) of Teduglutide
Tmax of teduglutide was reported.
Measured: 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
Terminal-phase Half-life (T1/2) of Teduglutide
T1/2 of teduglutide was reported.
Measured: 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
Apparent Clearance (CL/F) of Teduglutide
CL/F of teduglutide was reported.
Measured: 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
Apparent Volume of Distribution (Vz/F) of Teduglutide
Vz/F of teduglutide was reported.
Measured: 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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: From start of study drug administration up to EOT/ET (up to Week 28)
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
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.
Measured: From start of study drug administration up to EOT/ET (up to Week 28)
Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET)
Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET)
Change from baseline in pulse rate at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET)
Change from baseline in body temperature at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET)
Change from baseline in hemoglobin at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET)
Change from baseline in hematocrit at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Serum Blood Urea Nitrogen (BUN) at End of Treatment/Early Termination (EOT/ET)
Change from baseline in serum blood urea nitrogen at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET)
Change from baseline in creatinine at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET)
Change from baseline in urine sodium at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at End of Treatment/Early Termination (EOT/ET)
Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported.
Measured: EOT/ET (up to Week 28)
Change From Baseline in 48-Hour Urine Output at End of Treatment/Early Termination (EOT/ET)
Change from baseline in 48-hour urine output at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET)
Change from baseline in body weight at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Change From Baseline in Body Mass Index (BMI) at End of Treatment/Early Termination (EOT/ET)
Change from baseline in BMI at EOT/ET was reported.
Measured: Baseline, EOT/ET (up to Week 28)
Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination)
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.
Measured: Week 24/ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20186 Aug 2019

First posted10 Sep 2018
Study start6 Jul 2018
Primary completion6 Aug 2019
Study completion6 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03663582
Sponsor's protocol ID: SHP633-306
Status last verified: Jul 2020
First submitted: 28 Aug 2018
Last updated: 4 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome

All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week Safety, Efficacy, Pharmacokinetic Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Are Dependent on Parenteral Support
ClinicalTrials.gov ID: NCT03663582
Acronym / sponsor ID: SHP633-306
Conditions: Short Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 6 Jul 2018 (actual)
Primary completion: 6 Aug 2019 (actual)
Study completion: 6 Aug 2019 (actual)
First posted: 10 Sep 2018 (actual)
Results: Posted 4 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Teduglutide 0.05 mg	Experimental	Drug: Teduglutide, Device: Syringe, Device: Needle, Device: Vial Adapter for DeviceParticipants 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Ability to voluntarily provide written, signed, and informed consent to participate in the study.
Male or female 16 years of age or older at the time of signing informed consent.
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.
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.
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.

Key exclusion criteria (18 listed)

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.
Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months.
Use of octreotide, GLP-1 analogs, dipeptidyl peptidase-IV inhibitors, or enteral glutamine within 30 days.
Previous use of teduglutide.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TeduglutideTeduglutide 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.	Drug	Teduglutide 0.05 mg
SyringeTeduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).	Device	Teduglutide 0.05 mg
NeedleTeduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.	Device	Teduglutide 0.05 mg
Vial Adapter for DeviceVial adapter for device is approved for use in Japan by PMDA.	Device	Teduglutide 0.05 mg

Primary outcome

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.
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
AUC0-t of teduglutide was reported.
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
Cmax of teduglutide was reported.
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
Tmax of teduglutide was reported.
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
T1/2 of teduglutide was reported.
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
CL/F of teduglutide was reported.
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
Vz/F of teduglutide was reported.
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)
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.
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)
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.
Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported.
Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in pulse rate at EOT/ET was reported.
Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in body temperature at EOT/ET was reported.
Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in hemoglobin at EOT/ET was reported.
Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in hematocrit at EOT/ET was reported.
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)
Change from baseline in serum blood urea nitrogen at EOT/ET was reported.
Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in creatinine at EOT/ET was reported.
Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in urine sodium at EOT/ET was reported.
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)
Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported.
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)
Change from baseline in 48-hour urine output at EOT/ET was reported.
Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET)
Time frame: Baseline, EOT/ET (up to Week 28)
Change from baseline in body weight at EOT/ET was reported.
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)
Change from baseline in BMI at EOT/ET was reported.
Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination)
Time frame: Week 24/ET
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.

Results and safety

Results posted to the registry on 4 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teduglutide	7	6

Primary outcome: 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). Mean (Standard Deviation). Unit: Liter per week (L/Week)

Measure	Teduglutide n = 7
Value	-2.92 (3.463)

Population analysed: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Primary outcome: 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). Mean (Standard Deviation). Unit: Percent change

Measure	Teduglutide n = 7
Value	-22.19 (24.953)

Population analysed: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit.

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Teduglutide n = 6
Value	66.7

Population analysed: ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure.

Primary outcome: 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. Number. Unit: Percentage of participants

Measure	Teduglutide n = 6
Value	66.7

Adverse events

Time frame: From start of study drug administration up to EOT/ET (up to Week 28). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teduglutide	3 of 7 (42.9%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Shire

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teduglutide, Syringe and Needle in people with Short Bowel Syndrome, run by Shire at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03663582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.