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Completed

NCT Number: NCT01560403

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

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.

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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

Scripps Clinic & Research Foundation, La Jolla, California, United States

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About this study

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
  • Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
  • Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion criteria

  • None

Treatment and study plan

Teduglutide

Drug

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

Other names: Gattex

Primary outcomes

  1. Summary of Treatment-emergent Adverse Events

    Time frame: 12 months

    As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Acronym: STEPS3

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2012
Registry last updated
Jun 10, 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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