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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

NCT01560403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-10

Study results available
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Summary

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Teduglutide

0.05 mg/kg/day subcutaneously taken once per day for 12 months

Sponsors & Collaborators

  • 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
2012-05-21
Primary Completion
2013-07-23
Completion
2013-07-23

Countries

  • United States

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 NCT01560403 on ClinicalTrials.gov