A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS3)

Shire

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: Teduglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01560403

TED-C11-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:

  1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
  2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Teduglutide

Experimental group

Description:

0.05 mg/kg/day

Treatment:

Drug: Teduglutide