Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Short Bowel Syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Change From Baseline in Weekly PS Volume
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Percent Change From Baseline in Weekly PS Volume
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
timeFrame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
measure: Change From Baseline in Days Per Week of PS
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Change From Baseline in Plasma Citrulline Levels
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
timeFrame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
measure: Change From Baseline in 48-Hour Urine Output
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Clinically Significant Change From Baseline in BMI
timeFrame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
measure: Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
timeFrame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-ken
city: Hyogo
country: Japan
facility: Hyogo College of Medicine Hospital
city: Miyagi-Ken
country: Japan
facility: Tohoku University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: