A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome

Phase 1

• Conditions: Short Bowel Syndrome; MedDRA version: 14.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2009-011679-65-GB
• Lead Sponsor: PS Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

Subjects who meet all of the following criteria can be enrolled in this study:
1. Completion of 24-weeks of dosing in Study CL0600-020 or based on investigator and sponsor decision if the subject was required to stop dosing prematurely due to a non-drug related adverse experience or successful completion of stage I (optimization/stabilization) in Study CL0600-020 (i.e. qualification for randomization) after approximately 86 subjects have been randomized.

2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study CL0600-021 are performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 71
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

Exclusion criteria do not apply as only those subjects who have participated in Study CL0600-020 and do not meet the events necessitating withdrawal from the study as listed in Section 4.4.2 of this protocol are eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified