NCT00172185

Brief Summary

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Typical duration for phase_3

Geographic Reach
8 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2008

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

April 23, 2013

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

September 13, 2005

Results QC Date

March 12, 2013

Last Update Submit

May 12, 2021

Conditions

Short Bowel Syndrome

Keywords

Short Bowel SyndromeParenteral NutritionSBSTeduglutide

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Achieving a 20% Reduction at Week 28

    For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.

    28 weeks

Secondary Outcomes (1)

  • Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use

    6 months

Study Arms (2)

teduglutide 0.05 mg/kg/d

EXPERIMENTAL

0.05 mg/kg/d teduglutide subcutaneous injection

Drug: teduglutide 0.05 mg/kg/d

teduglutide 0.10 mg/kg/d

EXPERIMENTAL

0.10 mg/kg/d teduglutide subcutaneous injection

Drug: teduglutide 0.10 mg/kg/d

Interventions

teduglutide 0.05 mg/kg/dDRUG

0.05 mg/kg/d subcutaneous injection

Also known as: GATTEX
teduglutide 0.05 mg/kg/d
teduglutide 0.10 mg/kg/dDRUG

0.10 mg/kg/d subcutaneous injection

Also known as: GATTEX
teduglutide 0.10 mg/kg/d

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
  • Subjects who meet all of the following criteria can be enrolled in this study:
  • Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
  • Completion of protocol CL0600-004 (NCT00081458)

You may not qualify if:

  • History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • History of alcohol or drug abuse (within previous year)
  • Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
  • Pregnant or lactating women
  • Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania - Penn Nursing

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G2N2, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hôpital Huriez

Lille, 59037, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Hôpital Lariboisière

Paris, 92110, France

Location

Academic Medical Center, Department of Endocrinology & Metabolism

Amsterdam, 1100 DD, Netherlands

Location

Pracownia Żywienia

Olsztyn, 10-561, Poland

Location

Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

Warsaw, 00-416, Poland

Location

St. Mark's Hospital

Harrow, HAI3UJ, United Kingdom

Location

Related Publications (3)

  • Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

    PMID: 21317170RESULT

  • O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.

    PMID: 23333663RESULT

  • Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.

    PMID: 24134154RESULT

MeSH Terms

Conditions

Short Bowel SyndromeHyperphagia

Interventions

teduglutideALX-0600

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 10, 2005

Primary Completion

January 24, 2008

Study Completion

January 24, 2008

Last Updated

June 2, 2021

Results First Posted

April 23, 2013

Record last verified: 2021-05

Locations

PL(2)NL(1)BE(1)CA(3)FR(3)GB(1)DK(1)US(9)