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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR TEDUGLUTIDE RECOMBINANT

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Clinical Trials for Teduglutide Recombinant

Trial ID Title Status Sponsor Phase Summary
NCT00081458 Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Completed Shire Phase 3 The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
NCT00172185 Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458) Completed Shire Phase 3 The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
NCT00308438 Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008 Completed Shire Phase 2 The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
NCT00798967 Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects Completed Nycomed Phase 3 Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
NCT00798967 Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects Completed Shire Phase 3 Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
NCT00819468 Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function Completed NPS Pharma Phase 1 This is a study to compare the pharmacokinetic profile of teduglutide in healthy subjects with normal hepatic function with subjects who have moderate hepatic impairment.
NCT00820885 A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide Completed Shire Phase 1 The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Teduglutide Recombinant

Condition Name

Condition Name for Teduglutide Recombinant
Intervention Trials
Short Bowel Syndrome 17
Hyperlipidemias 4
Pharmacokinetics and Safety of Elevated Doses 1
Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for Teduglutide Recombinant
Intervention Trials
Syndrome 17
Short Bowel Syndrome 17
Hyperlipoproteinemias 4
Hyperlipidemias 4
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Clinical Trial Locations for Teduglutide Recombinant

Trials by Country

Trials by Country for Teduglutide Recombinant
Location Trials
United States 88
Canada 19
United Kingdom 12
Germany 9
Japan 7
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Trials by US State

Trials by US State for Teduglutide Recombinant
Location Trials
New York 8
Ohio 7
Pennsylvania 6
Georgia 5
California 5
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Clinical Trial Progress for Teduglutide Recombinant

Clinical Trial Phase

Clinical Trial Phase for Teduglutide Recombinant
Clinical Trial Phase Trials
Phase 4 3
Phase 3 15
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Teduglutide Recombinant
Clinical Trial Phase Trials
Completed 14
Not yet recruiting 8
Recruiting 7
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Clinical Trial Sponsors for Teduglutide Recombinant

Sponsor Name

Sponsor Name for Teduglutide Recombinant
Sponsor Trials
Shire 18
University Health Network, Toronto 4
Nycomed 3
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Sponsor Type

Sponsor Type for Teduglutide Recombinant
Sponsor Trials
Industry 24
Other 14
NIH 2
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