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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
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.
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hyogo College of Medicine Hospital
Hyōgo, Japan
Tohoku University Hospital
Miyagi-Ken, Japan
Osaka University Hospital
Osaka, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
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Vial adapter for device is approved for use in Japan by PMDA.
Yokohama Municipal Citizen's Hospital
Yokohama, Japan
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)