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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS3)

Primary Purpose

Short Bowel Syndrome

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Teduglutide

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Parenteral nutrition, TPN, HPN, PN, SBS, Short bowel syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion Criteria:

None

Sites / Locations

Scripps Clinic & Research Foundation
Emory University School of Medicine
Mount Sinai Medical Center
University of Pennsylvania
Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teduglutide

Arm Description

0.05 mg/kg/day

Outcomes

Primary Outcome Measures

Summary of Treatment-emergent Adverse Events

As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.

Secondary Outcome Measures

Full Information

NCT ID

NCT01560403

First Posted

March 13, 2012

Last Updated

May 26, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01560403

Brief Title

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Acronym

STEPS3

Official Title

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

May 21, 2012 (Actual)

Primary Completion Date

July 23, 2013 (Actual)

Study Completion Date

July 23, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Detailed Description

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Bowel Syndrome

Keywords

Parenteral nutrition, TPN, HPN, PN, SBS, Short bowel syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teduglutide

Arm Type

Experimental

Arm Description

0.05 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Teduglutide

Other Intervention Name(s)

Gattex

Intervention Description

0.05 mg/kg/day subcutaneously taken once per day for 12 months

Primary Outcome Measure Information:

Title

Summary of Treatment-emergent Adverse Events

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria: Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Scripps Clinic & Research Foundation

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Emory University School of Medicine

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing URL

https://vivli.org/ourmember/takeda/

Citations:

PubMed Identifier

29761915

Citation

Seidner DL, Fujioka K, Boullata JI, Iyer K, Lee HM, Ziegler TR. Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study. Nutr Clin Pract. 2018 Aug;33(4):520-527. doi: 10.1002/ncp.10092. Epub 2018 May 15.

Results Reference

result

Learn more about this trial

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

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