| Primary | Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | No | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Change From Baseline in Weekly PS Volume | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Mean | Standard Deviation | liter per week (L/Week) | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Percent Change From Baseline in Weekly PS Volume | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Mean | Standard Deviation | percent change | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Change From Baseline in Days Per Week of PS | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Mean | Standard Deviation | days per week | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Change From Baseline in Plasma Citrulline Levels | Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Mean | Standard Deviation | micromoles per liter | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
|---|
| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
|---|
| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | |
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| Primary | Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS | | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Change From Baseline in 48-Hour Urine Output | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Mean | Standard Deviation | Milliliter per day (mL/day) | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
|---|
| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in BMI | Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | | | | ID | Title | Description |
|---|
| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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| Primary | Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results | | The safety population included all enrolled participants in the study. | Posted | | Count of Participants | | Participants | | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | | | | ID | Title | Description |
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| OG000 | SHP633-306: Teduglutide 0.05 mg/kg | Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | | OG001 | TED-C14-004: Teduglutide 0.05 mg/kg | Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | | OG002 | Total Participants | All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. |
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