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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Teduglutide 0.05 mg 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
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.
Device: Syringe
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
Device: Needle
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Device: Vial Adapter for Device
Vial adapter for device is approved for use in Japan by PMDA.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants who Demonstrate at least 20 Percent (%) Reduction From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume [Baseline to each study visit until End of study (3 years)]
Number of participants who demonstrate at least 20% reduction in PN/IV volume will be assessed.
- Absolute Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume [Baseline to each study visit until End of study (3 years)]
Absolute change in PN/IV volume will be assessed.
- Relative Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume [Baseline to each study visit until End of study (3 years)]
Relative change in PN/IV volume will be assessed.
- Number of Participants who Completely Wean off Parenteral Nutrition Intravenous (PN/IV) Support [Baseline, End of the study (3 years)]
Number of participants who completely wean off PN/IV support will be assessed.
- Change From Baseline in Days per Week of Parenteral Nutrition Intravenous (PN/IV) Support [Baseline to each study visit until End of study (3 years)]
Change in days per week of PN/IV will be assessed.
- Change From Baseline in Plasma Citrulline [Baseline to each study visit until End of study (3 years)]
Change in plasma citrulline will be assessed.
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [From start of study treatment up to End of study (3 years)]
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs that start or deteriorate on or after the date of the first dose of investigational product.
- Change From Baseline in Blood Pressure [Baseline to each study visit until End of study (3 years)]
Change in blood pressure will be assessed.
- Change From Baseline in Pulse Rate [Baseline to each study visit until End of study (3 years)]
Change in pulse rate will be assessed.
- Change From Baseline in Body Temperature [Baseline to each study visit until End of study (3 years)]
Change in body temperature will be assessed.
- Change From Baseline in Hemoglobin [Baseline to each study visit until End of study (3 years)]
Change from baseline in hemoglobin will be assessed.
- Change From Baseline in Hematocrit [Baseline to each study visit until End of study (3 years)]
Change from baseline in hematocrit will be assessed.
- Change From Baseline in Serum Blood Urea Nitrogen [Baseline to each study visit until End of study (3 years)]
Change from baseline in serum blood urea nitrogen will be assessed.
- Change From Baseline in Creatinine [Baseline to each study visit until End of study (3 years)]
Change from baseline in creatinine will be assessed.
- Change From Baseline in Urine Sodium [Baseline to each study visit until End of study (3 years)]
Change from baseline in urine sodium will be assessed.
- Number of Participants Who Report Positive Specific Antibodies to Teduglutide [Baseline, every six months until End of study (3 years)]
Number of participants classified as having positive specific antibodies to teduglutide will be used to summarize the presence of antibodies.
- Change From Baseline in 48-Hour Urine Output [Baseline to each study visit until End of study (3 years)]
Urine output will be assessed.
- Change From Baseline in Body Weight [Baseline to each study visit until End of study (3 years)]
Changes in body weight will be assessed.
- Change From Baseline in Body Mass Index (BMI) [Baseline to each study visit until End of study (3 years)]
Changes in body mass index will be assessed.
- Number of Participants With Colonoscopy/Sigmoidoscopy Results [Baseline, Month 24, End of the study (3 years)]
Number of participants who have normal, abnormal but clinically insignificant, and abnormal clinically significant results will be assessed.
Eligibility Criteria
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.
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Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4.
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Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
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An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Exclusion Criteria:
There are no exclusion criteria for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hiroshima University Hospital | Hiroshima-shi | Hiroshima-ken | Japan | 734-8551 |
| 2 | Hyogo College of Medicine Hospital | Hyogo | Japan | 663-8501 | |
| 3 | Tohoku University Hospital | Miyagi-Ken | Japan | 980-8574 | |
| 4 | Osaka University Hospital | Osaka | Japan | 565-0871 | |
| 5 | Yokohama Municipal Citizen's Hospital | Yokohama | Japan | 240-8555 |
Sponsors and Collaborators
- Shire
- Takeda
Investigators
- Study Director: Study Director, Shire
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SHP633-307