Phase 3 N=11 Treatment

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

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03596164 ↗

Enrolled (actual)

Serious AEs

63.6%

Results posted

Mar 2023

Primary outcome: Primary: Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume — 3; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Teduglutide (Drug); Syringe (Device); Needle (Device); Vial Adapter for Device (Device)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume	3; 5	—
PRIMARY Change From Baseline in Weekly PS Volume	-7.45; -8.67	—
PRIMARY Percent Change From Baseline in Weekly PS Volume	-49.55; -52.52	—
PRIMARY Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)	1; 2	—
PRIMARY Change From Baseline in Days Per Week of PS	-2.3; -2.0	—
PRIMARY Change From Baseline in Plasma Citrulline Levels	12.96; 19.15	—
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	4; 7; 11; 3; 4; 7	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Values	0; 0; 0	—
PRIMARY Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS	3; 4; 7	—
PRIMARY Change From Baseline in 48-Hour Urine Output	428.8; 308.6; 352.3	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Change From Baseline in BMI	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results	0; 0; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03596164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.