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

Short Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596164
• Other study ID #: SHP633-307
• Status: Completed
• Phase: Phase 3
• Start date: July 9, 2018
• Est. completion date: January 13, 2022

Study information

• Verified date: February 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

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.

Device:
• Syringe
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
• Needle
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
• Vial Adapter for Device
Vial adapter for device is approved for use in Japan by PMDA.

Locations

Country	Name	City	State
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-ken
Japan	Hyogo College of Medicine Hospital	Hyogo
Japan	Tohoku University Hospital	Miyagi-Ken
Japan	Osaka University Hospital	Osaka
Japan	Yokohama Municipal Citizen's Hospital	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

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