DRUG
Teduglutide
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.
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
Status
Completed
Phase
Phase 3
Enrollment
11
Locations
5
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DEVICE
Syringe
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
DEVICE
Needle
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
DEVICE
Vial Adapter for Device
Vial adapter for device is approved for use in Japan by PMDA.
Timeline
From registration to results.
First posted
Jul 23, 2018
Study start
Jul 9, 2018
Primary completion
Jan 13, 2022
Study completion
Jan 13, 2022
Results posted
Mar 15, 2023
Registry updated
Mar 15, 2023
Outcomes
What the study measures.
Primary outcomes
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
Time frame · 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
Time frame · 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
Time frame · 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 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)
Change From Baseline in Days Per Week of PS
Time frame · 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 Plasma Citrulline Levels
Time frame · 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 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
Time frame · 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 outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: Participants who meet all of the following criteria will be enrolled in this study: 1. Ability to voluntarily provide written, signed, and informed consent to participate in the study. 2. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4. 3. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. 4. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: There are no exclusion criteria for this study.
Study locations
5 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hyogo College of Medicine Hospital
Hyōgo, Japan
Tohoku University Hospital
Miyagi-Ken, Japan
Osaka University Hospital
Osaka, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.