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The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 0.05 mg/kg/day administered by subcutaneous injection over a 24-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | 0.05 mg/kg/day administered by subcutaneous injection over a 24-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Absolute change from baseline in weekly PS volume at Week 24 was reported. | Baseline (stage 2), Week 24 |
| Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Percent change from baseline in weekly PS volume at Week 24 was reported. | Baseline (stage 2), Week 24 |
| Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 | Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24. | End of Stage 2 (up to Week 24) |
| Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 | Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported. | Baseline (stage 2), Week 24 |
| Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported. | Baseline (stage 2), Week 24 |
| Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported. | Baseline (stage 2), Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma | Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma |
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This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a 24-week treatment period in which all patients will receive teduglutide (Stage 2), and a long-term extension (Stage 3).
During the long-term extension (Stage 3), patients will continue to receive teduglutide for up to an additional 24 months or until teduglutide is commercially available, whichever comes earlier.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tohoku University Hospital | Sendai | Aoba-ku | 980-8574 | Japan | ||
| Yokohama Municipal Citizen's Hospital |
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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Screened participants underwent a maximum 8 week parenteral support (PS) optimization period and 4 to 8 week stabilization period (stage 1) followed by 24 weeks treatment period (stage 2), and a long-term extension period were all participants received same treatment of stage 2 in stage 3 and stage 4. Total study duration was up to 47 months.
The study was conducted at five centers in Japan between 18 December 2014 (first participant first visit) and 12 November 2018 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Teduglutide | Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population consisted of all participants in the intent-to-treat (ITT) population who received at least one dose of study drug. ITT population consists of all participants who are enrolled and eligible to enter Stage 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Teduglutide | Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Absolute change from baseline in weekly PS volume at Week 24 was reported. | Intent-to-treat (ITT) population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liter per week (L/week) | Baseline (stage 2), Week 24 |
|
From start of study treatment up to end of the study (up to 47 months)
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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 | Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombophlebitis | Vascular disorders | MedDRA 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.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 | Apr 3, 2017 | Oct 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2018 | Oct 29, 2019 | 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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| Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24 | Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported. | Week 24 |
| Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | Baseline (stage 3), Extension Month 24 |
| Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | Baseline (stage 3), Extension Month 24 |
| Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24 | Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | Baseline (stage 3), Extension Month 24 |
| Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | Baseline (stage 3), Extension Month 24 |
| Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | Baseline (stage 3), Extension Month 24 |
| Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Absolute change from baseline in weekly PS volume at end of treatment was reported. | Baseline (stage 4), End of Treatment (up to 47 months) |
| Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Percent change from baseline in weekly PS volume at end of treatment was reported. | Baseline (stage 4), End of Treatment (up to 47 months) |
| Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment | Absolute change from baseline in number of days per week of PS usage at end of treatment was reported. | Baseline (stage 4), End of Treatment (up to 47 months) |
| Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported. | Baseline (stage 4), End of Treatment (up to 47 months) |
| Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported. | Baseline (stage 4), End of Treatment (up to 47 months) |
Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated. |
| Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Maximum Concentration (Cmax) of Teduglutide in Plasma | Maximum concentration of teduglutide in plasma were evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Terminal Half-Life (t1/2) of Teduglutide in Plasma | Terminal half-life of teduglutide in plasma were evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Apparent Clearance (CL/F) of Teduglutide in Plasma | Apparent clearance of teduglutide in plasma were evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma | Apparent volume of distribution of teduglutide in plasma were evaluated. | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
| Yokohama |
| Hodogaya-ku |
| 240-8555 |
| Japan |
| Hospital of Hyogo College of Medicine | Hyōgo | Nishinomiya | 663-8501 | Japan |
| Osaka University Hospital, Department of Gastroenterological Surgery | Osaka | Suita | 565-0871 | Japan |
| Osaka University Hospital, Department of Pediatric Surgery | Osaka | Suita | 565-0871 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Percent change from baseline in weekly PS volume at Week 24 was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change in PS volume | Baseline (stage 2), Week 24 |
|
|
|
| Primary | Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 | Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Number | Percentage of Participants | End of Stage 2 (up to Week 24) |
|
|
|
| Primary | Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 | Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Days per week (days/week) | Baseline (stage 2), Week 24 |
|
|
|
| Primary | Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (stage 2), Week 24 |
|
|
|
| Primary | Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline (stage 2), Week 24 |
|
|
|
| Primary | Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24 | Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Primary | Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | L/week | Baseline (stage 3), Extension Month 24 |
|
|
|
| Primary | Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change in PS volume | Baseline (stage 3), Extension Month 24 |
|
|
|
| Primary | Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24 | Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days/week | Baseline (stage 3), Extension Month 24 |
|
|
|
| Primary | Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (stage 3), Extension Month 24 |
|
|
|
| Primary | Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline (stage 3), Extension Month 24 |
|
|
|
| Primary | Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Absolute change from baseline in weekly PS volume at end of treatment was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Mean | Standard Deviation | L/week | Baseline (stage 4), End of Treatment (up to 47 months) |
|
|
|
| Primary | Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Percent change from baseline in weekly PS volume at end of treatment was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Mean | Standard Deviation | Percent change in PS volume | Baseline (stage 4), End of Treatment (up to 47 months) |
|
|
|
| Primary | Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment | Absolute change from baseline in number of days per week of PS usage at end of treatment was reported. | ITT population consists of all participants who were enrolled and eligible to enter Stage 2. | Posted | Mean | Standard Deviation | days/week | Baseline (stage 4), End of Treatment (up to 47 months) |
|
|
|
| Primary | Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (stage 4), End of Treatment (up to 47 months) |
|
|
|
| Primary | Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported. | ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. | Posted | Mean | Standard Deviation | Percent change | Baseline (stage 4), End of Treatment (up to 47 months) |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma | Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated. | Pharmacokinetic (PK) analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | Nanogram*hour per milliliter (ng*h/mL) | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma | Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng*h/mL | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Teduglutide in Plasma | Maximum concentration of teduglutide in plasma were evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Median | Full Range | hour | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Terminal Half-Life (t1/2) of Teduglutide in Plasma | Terminal half-life of teduglutide in plasma were evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Median | Full Range | hour | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Apparent Clearance (CL/F) of Teduglutide in Plasma | Apparent clearance of teduglutide in plasma were evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data are considered sufficient and interpretable. | Posted | Mean | Standard Deviation | liter per hour (L/h) | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma | Apparent volume of distribution of teduglutide in plasma were evaluated. | PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | liter | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose |
|
|
|
| 1 |
| 11 |
| 7 |
| 11 |
| 11 |
| 11 |
| Enteritis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Non-systematic Assessment |
|
| Vascular pain | Vascular disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pancreatic duct dilatation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Injury associated with device | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Balanitis candida | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Trichophytosis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Stoma site reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Carcinoembryonic antigen increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Intestinal transit time increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Hypozincaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |