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

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

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.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Teduglutide; Device: Needle; Device: Vial Adapter for Device; Device: Syringe

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hyogo, Japan, 663-8501
    • Hyogo College of Medicine Hospital
  • Miyagi-Ken, Japan, 980-8574
    • Tohoku University Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Yokohama, Japan, 240-8555
    • Yokohama Municipal Citizen's Hospital
  • Hiroshima-ken
    • Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
      • Hiroshima University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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: 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.; Device: Syringe; Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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 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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Radiation-Protective Agents; Teduglutide
• Other Study ID Numbers: SHP633-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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, …).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No