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Completed

NCT Number: NCT00172185

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

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

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Erasme, Brussels, Belgium

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About this study

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

  • 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

Treatment and study plan

teduglutide 0.05 mg/kg/d

Drug

0.05 mg/kg/d subcutaneous injection

Other names: GATTEX

teduglutide 0.10 mg/kg/d

Drug

0.10 mg/kg/d subcutaneous injection

Other names: GATTEX

Primary outcomes

  1. Number of Subjects Achieving a 20% Reduction at Week 28

    Time frame: 28 weeks

    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.

Secondary outcomes

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

    Time frame: 6 months

    Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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