Back to resultsAn Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Primary Purpose
Short Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Teduglutide
Syringe
Needle
Vial Adapter for Device
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome
Eligibility Criteria
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.
Sites / Locations
- Hiroshima University Hospital
- Hyogo College of Medicine Hospital
- Tohoku University Hospital
- Osaka University Hospital
- Yokohama Municipal Citizen's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teduglutide 0.05 mg
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
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.
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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
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.
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.
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
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.
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.
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.
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03596164
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teduglutide 0.05 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Teduglutide
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Syringe
Intervention Description
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
Intervention Type
Device
Intervention Name(s)
Needle
Intervention Description
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Intervention Type
Device
Intervention Name(s)
Vial Adapter for Device
Intervention Description
Vial adapter for device is approved for use in Japan by PMDA.
Primary Outcome Measure Information:
Title
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
Description
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)
Title
Change From Baseline in Weekly PS Volume
Description
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)
Title
Percent Change From Baseline in Weekly PS Volume
Description
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)
Title
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)
Title
Change From Baseline in Days Per Week of PS
Description
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)
Title
Change From Baseline in Plasma Citrulline Levels
Description
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)
Title
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)
Title
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
Description
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)
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
Description
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)
Title
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Description
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)
Title
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)
Title
Change From Baseline in 48-Hour Urine Output
Description
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)
Title
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
Description
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)
Title
Number of Participants With Clinically Significant Change From Baseline in BMI
Description
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima-ken
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi-Ken
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama
ZIP/Postal Code
240-8555
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b5fd94db2bf003ab470f1
Description
To obtain more information on the study, click here/on this link
Learn more about this trial
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
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