Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome (SBS) Who Completed TED-C14-006

Description

This study will follow subjects who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric subjects with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C14-006.

Study Start Date

January, 01 2017

Estimated Completion Date

September 2019

Interventions

  • Other: SOC
  • Drug: Teduglutide

Study ID

Shire -- SHP633-304

Status

Recruiting

Trial ID

NCT02954458

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

34

Sponsor

Shire

Inclusion Criteria

    1. Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures. 2. Subject completed the TED-C14-006 study (including subjects in the standard of care treatment arm). 3. Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria

    1. There are no exclusion criteria for this study.

Gender

All

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (50)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Allyson McCrary 617-919-3619 Allyson.McCrary@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Allyson McCrary 617-919-3619 Allyson.McCrary@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Allyson McCrary 617-919-3619 Allyson.McCrary@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Allyson McCrary 617-919-3619 Allyson.McCrary@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Allyson McCrary 617-919-3619 Allyson.McCrary@childrens.harvard.edu
Columbia Unversity Medical Center - New York, New York 182.0 miles Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Columbia Unversity Medical Center - New York, New York 182.0 miles Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Columbia Unversity Medical Center - New York, New York 182.0 miles Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Rebecca Tibbetts 215-590-6853 TIBBETTSR@EMAIL.CHOP.EDU
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Rebecca Tibbetts 215-590-6853 TIBBETTSR@EMAIL.CHOP.EDU
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Rebecca Tibbetts 215-590-6853 TIBBETTSR@EMAIL.CHOP.EDU
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Rebecca Tibbetts 215-590-6853 TIBBETTSR@EMAIL.CHOP.EDU
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Rebecca Tibbetts 215-590-6853 TIBBETTSR@EMAIL.CHOP.EDU
Georgetown Childrens Research Network - Washington, District of Columbia 394.4 miles Catherine Lopez 202-444-1769 catherine.lopez@medstar.net
Georgetown Childrens Research Network - Washington, District of Columbia 394.4 miles Catherine Lopez 202-444-1769 catherine.lopez@medstar.net
Georgetown Childrens Research Network - Washington, District of Columbia 394.4 miles Catherine Lopez 202-444-1769 catherine.lopez@medstar.net
Georgetown Childrens Research Network - Washington, District of Columbia 394.4 miles Catherine Lopez 202-444-1769 catherine.lopez@medstar.net
Georgetown Childrens Research Network - Washington, District of Columbia 394.4 miles Catherine Lopez 202-444-1769 catherine.lopez@medstar.net
Duke Medical Center - Durham, North Carolina 609.0 miles Jennifer Thompson 919-681-6898 jennifer.thompson@duke.edu
Duke Medical Center - Durham, North Carolina 609.0 miles Jennifer Thompson 919-681-6898 jennifer.thompson@duke.edu
Duke Medical Center - Durham, North Carolina 609.0 miles Jennifer Thompson 919-681-6898 jennifer.thompson@duke.edu
Duke Medical Center - Durham, North Carolina 609.0 miles Jennifer Thompson 919-681-6898 jennifer.thompson@duke.edu
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Crystal Slaughter 513-636-0137 crystal.slaughter@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Crystal Slaughter 513-636-0137 crystal.slaughter@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Crystal Slaughter 513-636-0137 crystal.slaughter@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Crystal Slaughter 513-636-0137 crystal.slaughter@cchmc.org
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Crystal Slaughter 513-636-0137 crystal.slaughter@cchmc.org
Riley Hospital for Children - Indianapolist, Indiana 805.0 miles Laura Walker 317-944-4490 walkerlk@iu.edu
University of Wisconsin School of Medicine and Public Health - Madison, Wisconsin 932.2 miles Sarah Robbins 608-262-9799 robbins@surgery.wisc.edu
University of Wisconsin School of Medicine and Public Health - Madison, Wisconsin 932.2 miles Sarah Robbins 608-262-9799 robbins@surgery.wisc.edu
University of Wisconsin School of Medicine and Public Health - Madison, Wisconsin 932.2 miles Sarah Robbins 608-262-9799 robbins@surgery.wisc.edu
University of Wisconsin School of Medicine and Public Health - Madison, Wisconsin 932.2 miles Sarah Robbins 608-262-9799 robbins@surgery.wisc.edu
The Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Jill Povondra 402-559-2556 jill.povondra@unmc.edu
The Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Jill Povondra 402-559-2556 jill.povondra@unmc.edu
The Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles Jill Povondra 402-559-2556 jill.povondra@unmc.edu
Texas Childrens Hospital - Houston, Texas 1,609.9 miles Naqvi Mohammad 832-824-3634 mfnaqvi@texaschildrens.org
Texas Childrens Hospital - Houston, Texas 1,609.9 miles Naqvi Mohammad 832-824-3634 mfnaqvi@texaschildrens.org
Texas Childrens Hospital - Houston, Texas 1,609.9 miles Naqvi Mohammad 832-824-3634 mfnaqvi@texaschildrens.org
Texas Childrens Hospital - Houston, Texas 1,609.9 miles Naqvi Mohammad 832-824-3634 mfnaqvi@texaschildrens.org
Texas Childrens Hospital - Houston, Texas 1,609.9 miles Naqvi Mohammad 832-824-3634 mfnaqvi@texaschildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Jani Klein 206-987-0055 jani.klein@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Jani Klein 206-987-0055 jani.klein@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Jani Klein 206-987-0055 jani.klein@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Jani Klein 206-987-0055 jani.klein@seattlechildrens.org
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles Jani Klein 206-987-0055 jani.klein@seattlechildrens.org
Mattel Childrens Hospital UCLA - Los Angeles, California 2,605.2 miles Susan Feist 310-825-4349 sfeist@mednet.ucla.edu
Mattel Childrens Hospital UCLA - Los Angeles, California 2,605.2 miles Susan Feist 310-825-4349 sfeist@mednet.ucla.edu
Mattel Childrens Hospital UCLA - Los Angeles, California 2,605.2 miles Susan Feist 310-825-4349 sfeist@mednet.ucla.edu
Mattel Childrens Hospital UCLA - Los Angeles, California 2,605.2 miles Susan Feist 310-825-4349 sfeist@mednet.ucla.edu
Mattel Childrens Hospital UCLA - Los Angeles, California 2,605.2 miles Susan Feist 310-825-4349 sfeist@mednet.ucla.edu

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