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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1267-3327 | Other Identifier | WHO | |
| jRCT2021210035 | Registry Identifier | jRCT | |
| 2022-003572-16 | EudraCT Number |
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The main aims of the study are to check for side effects from teduglutide.
Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks. Participants may be able to repeat this treatment if they meet specific criteria. The study doctors will check for side effects from teduglutide until it becomes commercially available. The maximum duration of treatment is approximately 51.3 weeks.
A study of teduglutide in Japanese children with short bowel syndrome aged 4 months or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide 0.05 milligram per kilogram (mg/kg) | Experimental | Participants will receive teduglutide 0.05 milligram per kilogram [mg/kg] (0.025 mg/kg for participants with moderate or greater renal impairment) subcutaneous [SC] injection once daily in a 28-week treatment cycle consisting of a 24-week treatment period followed by a 4-week no treatment follow-up period for a maximum of 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | Teduglutide 0.05 mg/kg SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product. | From first dose of study drug until follow-up visit (4 weeks after end of treatment [EOT]/end of termination [ET] {up to 47.3-51.3 weeks}) |
| Number of Participants With Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event. | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Number of Participants With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AESI, whether serious or non-serious, is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event | Vital signs include systolic and diastolic blood pressure, heart rate and body temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PS Volume | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. An end of treatment (EOT) was defined as the last determination of endpoint of the last cycle. | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2: Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
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Inclusion Criteria:
Exclusion Criteria:
A parent/guardian who is not capable of understanding or not willing to adhere to the study visit schedule and other protocol requirements.
Clinically significant intestinal obstruction, active or recurrent pancreatic or biliary disease, or dysmotility that prevents the advancement of enteral intake.
Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, etc.
Severe, known dysmotility syndrome, such as pseudo-obstruction or persistent, severe, active gastroschisis-related dysmotility, that is the primary contributing factor to feeding intolerance and inability to reduce PS, prior to screening. Dysmotility is defined as severe if it is expected to limit the advancement of enteral feeding.
Major gastrointestinal (GI) surgical intervention including significant intestinal resection or bowel lengthening procedure within 3 months prior to screening (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections =<10 cm and endoscopic procedures are allowed).
Cardiac disease that makes the patient vulnerable to changes in fluid status.
History of cancer or known cancer predisposition syndrome, such as juvenile polyposis or Beckwith-Wiedemann syndrome, or first degree relative with early onset of GI cancer (including hepatobiliary and pancreatic cancer).
Concurrent treatment with glucagon-like peptide-2 (GLP-2), human growth hormone, or analogs of these hormones within 6 months prior to the screening visit, or concurrent treatment with octreotide, or GLP-1 analogs within 30 days prior to the screening visit.
Concurrent treatment with biological therapy (eg, anti-tumor necrosis factor [anti-TNF]) for active Crohn's disease within 6 months prior to the screening visit.
Participation in a clinical study using an experimental drug (other than glutamine or omegaven) within 3 months or 5.5 half-lives of the experimental drug, whichever is longer, prior to the screening visit and for the duration of the study.
Known or suspected intolerance or hypersensitivity to the study drug, closely related compounds, or any of the stated ingredients.
Signs of active, severe, or unstable clinically significant hepatic impairment during the screening period as meeting at least 2 of any of the following parameters:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tsukuba Hospital | Tsukuba | Ibaraki | Japan | |||
| Tohoku University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41454663 | Derived | Masumoto K, Muto M, Sasaki T, Shikamura M, Tanaka T, Sakui S, Miyamoto M, Nakano H, Kondo T, Ieiri S. Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study. Pediatr Int. 2026 Jan-Dec;68(1):e70301. doi: 10.1111/ped.70301. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
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Pediatric participants with a diagnosis of short bowel syndrome (SBS) dependent on parenteral support (PS) were enrolled in the study based on the eligibility criteria to receive teduglutide.
Three participants took part in the study at six investigative sites in Japan from 4 January 2022 to 27 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teduglutide | Participants received teduglutide 0.05 milligram per kilogram [mg/kg] (0.025 mg/kg for participants with moderate or greater renal impairment) subcutaneous [SC] injection once daily in a 28-week treatment cycle consisting of a 24-week treatment period followed by a 4-week no treatment follow-up period for a maximum of 3 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set included all participants who received at least 1 dose of study teduglutide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Teduglutide | Participants received teduglutide 0.05 milligram per kilogram [mg/kg] (0.025 mg/kg for participants with moderate or greater renal impairment) subcutaneous [SC] injection once daily in a 28-week treatment cycle consisting of a 24-week treatment period followed by a 4-week no treatment follow-up period for a maximum of 3 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after end of treatment [EOT]/end of termination [ET] {up to 47.3-51.3 weeks}) |
|
From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks])
Safety Analysis Set included all participants who received at least 1 dose of study teduglutide.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teduglutide | Participants received teduglutide 0.05 milligram per kilogram [mg/kg] (0.025 mg/kg for participants with moderate or greater renal impairment) subcutaneous [SC] injection once daily in a 28-week treatment cycle consisting of a 24-week treatment period followed by a 4-week no treatment follow-up period for a maximum of 3 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA 26 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood iron increased | Investigations | MedDRA 26 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | 1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2022 | Mar 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2023 | Mar 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
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| From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Change From Baseline in Body Weight Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for age Z-score below -2 indicates underweight. | Baseline, EOT (up to 47.3-51.3 weeks) |
| Change From Baseline in Height Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a height for age Z-score below -2 indicates stunted. | Baseline, EOT (up to 47.3-51.3 weeks) |
| Change From Baseline in Head Circumference Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to the Food and Nutrition Technical Assistance (FANTA) Guide to Anthropometry used for assessment of this outcome measure, a head circumference for age Z-score below -2 indicates small head circumference. | Baseline, EOT (up to 47.3-51.3 weeks) |
| Change From Baseline in Weight-for-Length Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for length Z-score below -2 indicates wasted (recent and severe weight loss). | Baseline, EOT (up to 47.3-51.3 weeks) |
| Number of Participants With Any Laboratory Safety Finding Reported as an Adverse Event | Laboratory safety parameters included biochemistry, hematology, and urinalysis. | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Number of Participants With a Change in Urine Output Reported as an Adverse Event | Urine and stool output was recorded and calculated in the output diary over a 48-hour period of parenteral support (PS) and enteral nutrition (EN) stability before every site visit and within 1 week of implementing a change in the PS prescription. | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Number of Participants With a Change in Stool Output Reported as an Adverse Event | Urine and stool output was recorded and calculated in the output diary over a 48-hour period of PS and EN stability before every site visit and within 1 week of implementing a change in the PS prescription. | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
| Percent Change From Baseline in PS Volume | Percent change from baseline in PS volume was calculated as follows; (PS volume at each point [Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT] - PS volume at baseline)/ PS volume at baseline *100 (percent). PS (parenteral nutrition or intravenous fluids) was to be considered for managing nutritional support in terms of volume and calories during the treatment period. An EOT was defined as the last determination of endpoint of the last cycle. | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
| Number of Participants Who Demonstrate at Least 20 Percent (%) Reduction From Baseline in PS Volume | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. An EOT was defined as the last determination of endpoint of the last cycle. | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
| Number of Participants Who Achieved Enteral Autonomy | Achieving enteral autonomy is defined as complete weaning off PS. PS (parenteral nutrition or intravenous fluids) was to be considered for managing nutritional support in terms of volume and calories during the treatment period. | Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
| Change From Baseline in Number of Days Per Week of PS Usage at EOT | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT, and overall EOT (for 47.3-51.3 weeks) [cycle length=28 weeks] |
| Sendai |
| Miyagi |
| Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | Japan |
| Akita University Hospital | Akita | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Kagoshiha University Hospital | Kagoshima | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height for Age Z-Score at Baseline | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to the World Health Organization (WHO) Child Growth Standards used for assessment of this characteristic, a height for age Z-score below -2 indicates stunted. | Mean | Standard Deviation | Z score |
|
| Weight for Age Z-Score at Baseline | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this characteristic, a weight for age Z-score below -2 indicates underweight. | Mean | Standard Deviation | Z score |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AESI, whether serious or non-serious, is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as an Adverse Event | Vital signs include systolic and diastolic blood pressure, heart rate and body temperature. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Primary | Change From Baseline in Body Weight Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for age Z-score below -2 indicates underweight. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Mean | Standard Deviation | Z score | Baseline, EOT (up to 47.3-51.3 weeks) |
|
|
|
| Primary | Change From Baseline in Height Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a height for age Z-score below -2 indicates stunted. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Mean | Standard Deviation | Z score | Baseline, EOT (up to 47.3-51.3 weeks) |
|
|
|
| Primary | Change From Baseline in Head Circumference Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to the Food and Nutrition Technical Assistance (FANTA) Guide to Anthropometry used for assessment of this outcome measure, a head circumference for age Z-score below -2 indicates small head circumference. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Z score | Baseline, EOT (up to 47.3-51.3 weeks) |
|
|
|
| Primary | Change From Baseline in Weight-for-Length Z-Score at EOT | A Z-score is the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). According to WHO Child Growth Standards used for assessment of this outcome measure, a weight for length Z-score below -2 indicates wasted (recent and severe weight loss). | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | Z score | Baseline, EOT (up to 47.3-51.3 weeks) |
|
|
|
| Primary | Number of Participants With Any Laboratory Safety Finding Reported as an Adverse Event | Laboratory safety parameters included biochemistry, hematology, and urinalysis. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Primary | Number of Participants With a Change in Urine Output Reported as an Adverse Event | Urine and stool output was recorded and calculated in the output diary over a 48-hour period of parenteral support (PS) and enteral nutrition (EN) stability before every site visit and within 1 week of implementing a change in the PS prescription. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Primary | Number of Participants With a Change in Stool Output Reported as an Adverse Event | Urine and stool output was recorded and calculated in the output diary over a 48-hour period of PS and EN stability before every site visit and within 1 week of implementing a change in the PS prescription. | Safety Analysis Set included all participants who received at least 1 dose of study teduglutide. | Posted | Count of Participants | Participants | From first dose of study drug until follow-up visit (4 weeks after EOT/ET [up to 47.3-51.3 weeks]) |
|
|
|
| Secondary | Change From Baseline in PS Volume | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. An end of treatment (EOT) was defined as the last determination of endpoint of the last cycle. | Full Analysis Set included all enrolled participants, who were not screen failures, regardless of whether participants took any dose of teduglutide in the study. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Mean | Standard Deviation | milliliters per kilograms (mL/kg)/day | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2: Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
|
|
|
| Secondary | Percent Change From Baseline in PS Volume | Percent change from baseline in PS volume was calculated as follows; (PS volume at each point [Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT] - PS volume at baseline)/ PS volume at baseline *100 (percent). PS (parenteral nutrition or intravenous fluids) was to be considered for managing nutritional support in terms of volume and calories during the treatment period. An EOT was defined as the last determination of endpoint of the last cycle. | Full Analysis Set included all enrolled participants, who were not screen failures, regardless of whether participants took any dose of teduglutide in the study. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
|
|
|
| Secondary | Number of Participants Who Demonstrate at Least 20 Percent (%) Reduction From Baseline in PS Volume | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. An EOT was defined as the last determination of endpoint of the last cycle. | Full Analysis Set included all enrolled participants, who were not screen failures, regardless of whether participants took any dose of teduglutide in the study. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Count of Participants | Participants | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
|
|
|
| Secondary | Number of Participants Who Achieved Enteral Autonomy | Achieving enteral autonomy is defined as complete weaning off PS. PS (parenteral nutrition or intravenous fluids) was to be considered for managing nutritional support in terms of volume and calories during the treatment period. | Full Analysis Set included all enrolled participants, who were not screen failures, regardless of whether participants took any dose of teduglutide in the study. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Count of Participants | Participants | Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT and overall EOT (for up to 47.3-51.3 weeks) [cycle length=28 weeks] |
|
|
|
| Secondary | Change From Baseline in Number of Days Per Week of PS Usage at EOT | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume and calories during the treatment period. | Full Analysis Set included all enrolled participants, who were not screen failures, regardless of whether participants took any dose of teduglutide in the study. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Mean | Standard Deviation | days per week | Baseline, Cycle 1 = Week 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 2 = Week 0, 1, 2, 4, 8, 12, 16, 20, 24, and EOT, Cycle 3 = Week 0, 1, 2, and EOT, and overall EOT (for 47.3-51.3 weeks) [cycle length=28 weeks] |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| Catheter site pruritus | General disorders | MedDRA 26 | Systematic Assessment |
|
| Device breakage | Product Issues | MedDRA 26 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Vascular device occlusion | General disorders | MedDRA 26 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Catheter site rash | General disorders | MedDRA 26 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
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| Parainfluenzae virus infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Skin candida | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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