A Study of the Safety and Efficacy of Teduglutide in Subjects with Parenteral Nutrition-Dependant Short Bowel Syndrome Who Completed Protocol CL0600-004 - N/A

Phase 1

Conditions: Short Bowel Syndrome (SBS) refers to the clinical situation whereby a significant reduction in the absorptive capacity of the intestine results from inadequate anatomical or functional length of residual small intestine following surgical resection. These patients are highly prone to malnutrition, diarrhoea, and dehydration due to the reduced intestinal capacity to absorb macronutrients, water and electrolytes.

Registration Number: EUCTR2004-000439-27-DK

Lead Sponsor: PS Allelix Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Subjects who meet all of the following criteria can be enrolled in this study:

1. Signed and dated informed consent form (ICF) before any study-related
procedures are performed

2. Completion of protocol CL0600-004
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded:

1. History of cancer or clinically significant lymphoproliferative disease with
fewer than 5 years documented disease-free state. This does not include
resected cutaneous basal or squamous cell carcinoma, or in situ cervical
cancer

2. History of alcohol or drug abuse (within previous year)

3. Prior use of native GLP-2 within 3 months of screening visit

4. Pregnant or lactating women

5. Any condition or circumstance, which in the investigator’s opinion would put
the subject at any undue risk, prevent completion of the study, or interfere with
analysis of the study results

6. Failure to adhere to required washout periods

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the long-term safety and efficacy of daily sc (subcutaneous) administration of teduglutide in subjects with PN (Parenteral Nutrition)-dependent SBS.<br><br>The primary objective is to evaluate the long-term safety and tolerability of daily teduglutide dosing for up to 12 months in adult subjects with SBS dependent on PN.;Secondary Objective: The secondary objective of the study is to evaluate the long-term effects of teduglutide dosing on reductions in PN for those subjects who received teduglutide or placebo in protocol CL0600-004.;Primary end point(s): Reduction in PN volume forms the basis for most of the efficacy evaluations. Plasma citrulline levels will be measured in all subjects to assess absorptive enterocyte mass. Quality of life will also be evaluated.

Secondary Outcome Measures