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
- Conditions
- Short Bowel Syndrome
- Interventions
- Registration Number
- NCT03596164
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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.
There are no exclusion criteria for this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Teduglutide 0.05 mg Vial Adapter for Device 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. Teduglutide 0.05 mg Needle 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. Teduglutide 0.05 mg Syringe 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. Teduglutide 0.05 mg Teduglutide 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Plasma Citrulline Levels Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Change From Baseline in Days Per Week of PS Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Change From Baseline in Weekly PS Volume Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Percent Change From Baseline in Weekly PS Volume Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Change From Baseline in 48-Hour Urine Output Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
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) 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) 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 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) Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
Number of Participants With Clinically Significant Change From Baseline in BMI Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Tohoku University Hospital
🇯🇵Miyagi-Ken, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Japan
Yokohama Municipal Citizen's Hospital
🇯🇵Yokohama, Japan
Hiroshima University Hospital
🇯🇵Hiroshima-shi, Hiroshima-ken, Japan