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Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

NCT00930644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-06-11

Study results available
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Summary

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

teduglutide

0.05 mg/kg/day subcutaneously taken once per day for 24 months

Sponsors & Collaborators

  • Nycomed Germany GmbH

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-21
Primary Completion
2013-01-24
Completion
2013-01-24

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930644 on ClinicalTrials.gov