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 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SHP633-307
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (15)

• 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)

Study Arms (1)

Teduglutide 0.05 mg

EXPERIMENTAL

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; Device: Syringe; Device: Needle; Device: Vial Adapter for Device

Interventions

Teduglutide DRUG

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.

Teduglutide 0.05 mg

Syringe DEVICE

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

Teduglutide 0.05 mg

Needle DEVICE

Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.

Teduglutide 0.05 mg

Vial Adapter for Device DEVICE

Vial adapter for device is approved for use in Japan by PMDA.

Teduglutide 0.05 mg

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Hyogo College of Medicine Hospital

Hyōgo, 663-8501, Japan

Location

Tohoku University Hospital

Miyagi-Ken, 980-8574, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, 240-8555, Japan

Location

Related Links

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

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide; Syringes; Needles

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 23, 2018
• Study Start: July 9, 2018
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)