An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

Official Title
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An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: Teduglutide
* Device: Syringe
* Device: Needle
* Device: Vial Adapter for Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who meet all of the following criteria will be enrolled in this study: Ability to voluntarily provide written, signed, and informed consent to participate in the study. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teduglutide 0.05 mg<br>Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued. | Drug: Teduglutide<br>* Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.<br>Device: Syringe<br>* Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.<br>Device: Needle<br>* Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.<br>Device: Vial Adapter for Device<br>* Vial adapter for device is approved for use in Japan by PMDA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) |  | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |  | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS |  | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| 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. | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | 
| Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results |  | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) |