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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

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Takeda

Status and phase

Completed
Phase 3

Conditions

Short Bowel Syndrome

Treatments

Drug: Teduglutide
Device: Vial Adapter for Device
Device: Needle
Device: Syringe

Study type

Interventional

Funder types

Industry

Identifiers

NCT03596164
SHP633-307

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Teduglutide 0.05 mg
Experimental group
Description:
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.
Treatment:
Device: Vial Adapter for Device
Device: Syringe
Device: Needle
Drug: Teduglutide

Trial documents
2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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