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Completed

NCT Number: NCT03596164

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hiroshima University Hospital, Hiroshima, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

There are no exclusion criteria for this study.

Treatment and study plan

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.

Syringe

Device

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

needle

Device

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

Vial Adapter for Device

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. 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)

  8. 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.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

  12. 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)

    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.

  13. 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)

    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.

  14. 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)

    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.

  15. 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)

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2018
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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