Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Belgium, Canada, Finland, Italy, United Kingdom
1 trial · 1 completed · 1 with posted results
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
NCT029544589 Jan 2017 to 5 Nov 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.
Experimental
Standard of care (SOC) treatment +/- teduglutide (TED)
Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.
Outcomes the sponsor listed as primary.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame · From start of study drug administration up to follow-up (up to 46 months)
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 that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.
Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram \[kg\]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).
Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF).
Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).
Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2).
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \[g/kg/day\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).
Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \[g/kg/day\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day).
Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day).
Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day.
Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.
Change From Baseline in Average Bristol Stool Form Score at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Fecal output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized separately the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1- Separate hard lumps, hard to pass, 2- Sausage-shaped, but lumpy, 3- Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid.
Number of Participants With Positive Specific Antibodies at End of Study (EOS)
Time frame · At EOS (up to 46 months)
Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.
Change From Baseline in Body Weight Z-score at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Body Weight Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Body weight was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Height Z-score at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Height Z-score at Last Visit During Non-Teduglutide Treatment
Time frame · Baseline, Last visit in NT (up to Month 39)
Height was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Head Circumference Z-score at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Head Circumference Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
Head circumference was measured using Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Body Mass Index (BMI) Z-score at EOT of Last Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Change From Baseline in Body Mass Index (BMI) Z-score at Last Visit During Non-Teduglutide Treatment (NT)
Time frame · Baseline, Last visit in NT (up to Month 39)
BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.
Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Diary Parenteral Support (PS) Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in diary PS volume at EOT of last cycle during teduglutide treatment was reported.
Number of Participants Who Achieved At Least 20 Percent (%), 50%, and 75% Reduction From Baseline in Prescribed PS Volume at End of Treatment (EOT) of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Number of participants who achieved at least 20%, 50%, and 75% reduction from baseline in prescribed PS volume at EOT of east cycle during teduglutide treatment was reported.
Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in diary PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent Change from baseline in prescribed PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in diary PS caloric intake at EOT of each cycle during teduglutide treatment was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
Percent Change From Baseline in Diary PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in diary PS Caloric intake at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Percent Change From Baseline in Prescribed PS Caloric Intake at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in prescribed PS caloric intake at EOT of each cycle during teduglutide treatment was reported.
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during teduglutide treatment was reported.
Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Percent Change From Baseline in Hours Per Day of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in hours per day of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of diary PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Percent Change From Baseline in Hours Per Day of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in hours per day of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Hours per day of dairy PS was calculated as: Hours per day of actual PS = (sum of hours per day for each day that PS intake data is recorded within the 7 days prior to the visit / number of days that PS hours per day data is recorded as non-zero within the 7 days prior to the visit).
Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \* 7.
Percent Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \* 7.
Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \* 7
Percent Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment
Time frame · Baseline, EOT of each cycle 1, 2, 3, 4, 5, and 6 (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks)
Percent change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of dairy PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) \* 7.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 6 |
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | 3 |
| Teduglutide /Non-teduglutide Treatment (TED/NTT) | 1 |
| Teduglutide/Teduglutide Treatment (TED/TED) | 50 |
| Group | Value (mL/kg/day) | Spread |
|---|---|---|
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0.26 | 1.692 |
| Teduglutide/Teduglutide Treatment (TED/TED) | 2.51 | 22.607 |
| Group | Value (mL/kg/day) | Spread |
|---|---|---|
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | -0.89 | 7.431 |
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | not posted | – |
| Teduglutide /Non-teduglutide Treatment (TED/NTT) | 15.01 | NA |
| Teduglutide/Teduglutide Treatment (TED/TED) | -6.87 | 26.299 |
| Group | Value (Stools per day) | Spread |
|---|---|---|
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | not posted | – |
| Teduglutide/Teduglutide Treatment (TED/TED) | -0.47 | 2.272 |
| Group | Value (Stools per day) | Spread |
|---|---|---|
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | -0.50 | 0.913 |
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | not posted | – |
| Teduglutide /Non-teduglutide Treatment (TED/NTT) | not posted | – |
| Teduglutide/Teduglutide Treatment (TED/TED) | 0.38 | 1.780 |
| Group | Value (g/kg/day) | Spread |
|---|---|---|
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0.00 | NA |
| Teduglutide/Teduglutide Treatment (TED/TED) | -11.35 | 25.667 |
| Group | Value (g/kg/day) | Spread |
|---|---|---|
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 0.31 | NA |
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | not posted | – |
| Teduglutide /Non-teduglutide Treatment (TED/NTT) | not posted | – |
| Teduglutide/Teduglutide Treatment (TED/TED) | -4.98 | 20.892 |
| Group | Value (mL/kg/day) | Spread |
|---|---|---|
| Non-teduglutide/Teduglutide Treatment (NTT/TED) | -12.52 | 11.675 |
| Teduglutide/Teduglutide Treatment (TED/TED) | 12.16 | 35.079 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Non-teduglutide/Non-teduglutide Treatment (NTT/NTT)Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study. | 0 / 7 | 4 / 7 | 6 / 7 |
| Non-teduglutide/Teduglutide Treatment (NTT/TED)Participants who participated in standard of care arm in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study and received 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily up to 121 weeks. | 0 / 3 | 2 / 3 | 3 / 3 |
| Teduglutide /Non-teduglutide Treatment (TED/NTT)Participants who received teduglutide in the core study TEDC14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study but did not receive any teduglutide treatment in this extension study. | 0 / 1 | 1 / 1 | 1 / 1 |
| Teduglutide/Teduglutide Treatment (TED/TED)Participants who received teduglutide in the core study TED-C14-006 \[NCT02682381\] or SHP633-301 \[NCT03571516\] were enrolled into this extension study received 0.05 mg/kg of teduglutide SC injections once daily up to 142 weeks. | 2 / 50 | 41 / 50 | 50 / 50 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2026
Wendel et al. 2026Journal of pediatric gastroenterology and nutritioncited by 1
PMID 41858082PMC13342760DOI 10.1002/jpn3.70358PUB-41858082
PubMed tag: none · 2024
Wales et al. 2024Journal of pediatric gastroenterology and nutritioncited by 15
PMID 38873891DOI 10.1002/jpn3.12276PUB-38873891
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