Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT03596164Other idSHP633-307

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 11 participants (actual)
Sponsor: Takeda · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Japan
Start: 9 Jul 2018
Primary completion: 13 Jan 2022
Completion: 13 Jan 2022
First posted: 23 Jul 2018
Last update posted: 15 Mar 2023
Conditions: Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020202120222023

Ph 3
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
NCT03596164
9 Jul 2018 to 13 Jan 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

TeduglutideDrug
SyringeDevice
NeedleDevice
Vial Adapter for DeviceDevice

Arms1

Experimental
Teduglutide 0.05 mg
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 outcomes15

Outcomes the sponsor listed as primary.

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)
Registry 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.
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)
Registry 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.
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)
Registry 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.
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)
Registry 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.
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)
Registry 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.
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)
Registry 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.
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
Time frame · Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Registry 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.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time frame · Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Registry 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.
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
Time frame · Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Registry 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.
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
Time frame · Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Registry 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.
Number of Participants With Clinically Significant Change From Baseline in BMI
Time frame · Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Registry 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.
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume

Group	Value (Participants)
SHP633-306: Teduglutide 0.05 mg/kg	3
TED-C14-004: Teduglutide 0.05 mg/kg	5

Primary outcomeMean· Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Change From Baseline in Weekly PS Volume

Group	Value (liter per week (L/Week))	Spread
SHP633-306: Teduglutide 0.05 mg/kg	-7.45	7.908
TED-C14-004: Teduglutide 0.05 mg/kg	-8.67	7.450

Primary outcomeMean· Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Percent Change From Baseline in Weekly PS Volume

Group	Value (percent change)	Spread
SHP633-306: Teduglutide 0.05 mg/kg	-49.55	41.411
TED-C14-004: Teduglutide 0.05 mg/kg	-52.52	39.828

Primary outcomeCount of participants· From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)

Group	Value (Participants)
SHP633-306: Teduglutide 0.05 mg/kg	1
TED-C14-004: Teduglutide 0.05 mg/kg	2

Primary outcomeMean· Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Change From Baseline in Days Per Week of PS

Group	Value (days per week)	Spread
SHP633-306: Teduglutide 0.05 mg/kg	-2.3	3.30
TED-C14-004: Teduglutide 0.05 mg/kg	-2.0	3.42

Primary outcomeMean· Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Change From Baseline in Plasma Citrulline Levels

Group	Value (micromoles per liter)	Spread
SHP633-306: Teduglutide 0.05 mg/kg	12.96	5.568
TED-C14-004: Teduglutide 0.05 mg/kg	19.15	18.851

Primary outcomeCount of participants· 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)

Group	Value (Participants)
SHP633-306: Teduglutide 0.05 mg/kg	4
TED-C14-004: Teduglutide 0.05 mg/kg	7
Total Participants	11

Primary outcomeCount of participants· 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 Electrocardiogram (ECG) Values

Group	Value (Participants)
SHP633-306: Teduglutide 0.05 mg/kg	0
TED-C14-004: Teduglutide 0.05 mg/kg	0
Total Participants	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SHP633-306: Teduglutide 0.05 mg/kgParticipants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.	1 / 4	3 / 4	4 / 4
TED-C14-004: Teduglutide 0.05 mg/kgParticipants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.	0 / 7	4 / 7	7 / 7
Total ParticipantsAll participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.	1 / 11	7 / 11	11 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 16 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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