Safety and Effectiveness of teduglutide (Revestive ®) treatment in paediatric patients with chronic intestinal failure due to short bowel syndrome – an observational study

Recruiting

• Conditions: K91.2; Postsurgical malabsorption, not elsewhere classified

• Registration Number: DRKS00021006
• Lead Sponsor: Klinik für Kinder- und JugendmedizinUniversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children 1 to 18 years of age receiving treatment with Revestive® in Germany and Austria according to the drug license
• Signed informed consent from parents or legal representative

Exclusion Criteria

Missing signed consent and off-label use

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Reduction of parenteral nutrition - evaluate the efficacy of Revestive® application

Secondary Outcome Measures

Name	Time	Method
Secondary objectives:<br>• Impact on diarrhoea: Changes of stool output – number of stools per day and stool consistency<br>• Impact on weight and growth development<br>• Impact on vital parameters (blood pressure, heart frequency)<br>• Impact on urine output<br>• Impact on quality of life<br>• Impact on pre-existing diseases/co-morbidities (e.g. intestinal failure associated liver disease)<br>• Registration of treatment associated adverse events – evaluate long-term safety<br>• Recording Revestive® treatment daily dosage, duration and causes for discontinuation<br><br>Data aquisition will be assessed for each objective at start of treatment, 6 weeks, and every 6 months as well as at end of treatment and 6, 12 and 24 months thereafter.