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

Shire

Status and phase

Completed

Phase 3

Conditions

Short Bowel Syndrome

Treatments

Drug: teduglutide 0.10 mg/kg/d

Drug: teduglutide 0.05 mg/kg/d

Study type

Interventional

Funder types

Industry

Identifiers

NCT00172185

2004-000439-27 (EudraCT Number)

CL0600-005

Details and patient eligibility

About

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

Full description

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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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