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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223972

Enrollment

Registered

2018-07-06

Start date

2018-07-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome (SBS)

Interventions

investigational material(s) Generic name etc : Teduglutide INN of investigational material : - Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who met all of the following criteria were eligible for inclusion in the 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

Exclusion criteria: There are no exclusion criteria for this study.

Design outcomes

Primary

Measure	Time frame
efficacy 1.Number of Participants who Demonstrate at least 20 Percent (%) Reduction from Baseline in Parenteral Support (PS) Volume at End of Study (EOS) Time Frame: From Baseline up to EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) 7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 2.Change From Baseline in PS Volume at EOS Time Frame: Baseline, EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) 7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 3.Percent Change from Baseline in Weekly PS Volume at EOS Time Frame: Baseline, EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) *7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 4.Number of Participants who were Completely Weaned Off PS at EOS Time Frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) efficacy 5.Change from Baseline in Days Per Week of PS at EOS Time Frame: Baseline, EOS (up to approximately 42 months) Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 6.Change from Baseline in Plasma Citrulline Levels at EOS Time Frame: Baseline, EOS (up to approximately 42 months) 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 refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). safety 7.Number of Participan	—

Measure

Time frame

efficacy 1.Number of Participants who Demonstrate at least 20 Percent (%) Reduction from Baseline in Parenteral Support (PS) Volume at End of Study (EOS) Time Frame: From Baseline up to EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) *7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 2.Change From Baseline in PS Volume at EOS Time Frame: Baseline, EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) *7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 3.Percent Change from Baseline in Weekly PS Volume at EOS Time Frame: Baseline, EOS (up to approximately 42 months) The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values) *7. Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 4.Number of Participants who were Completely Weaned Off PS at EOS Time Frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) efficacy 5.Change from Baseline in Days Per Week of PS at EOS Time Frame: Baseline, EOS (up to approximately 42 months) Baseline refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). efficacy 6.Change from Baseline in Plasma Citrulline Levels at EOS Time Frame: Baseline, EOS (up to approximately 42 months) 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 refers to the baseline value of the core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]). safety 7.Number of Participan

—

Secondary

Measure	Time frame
other Not Applicable	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026