Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733066
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-08-29
Brief Title:
Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MatchedQoL
Brief Summary:
The aim of this prospective longitudinal study is to compare the quality of life of short bowel patients prior to and on teduglutide treatment with a non-treated patient group in a matched-pair design
Detailed Description:
Short bowel syndrome SBS is a malabsorptive disorder mostly caused by surgical interventions which may result in chronic intestinal failure cIF The incidence is progressively increasing due to more aggressive surgical and medical approaches Parenteral nutrition is still the mainstay of treatment for patients with irreversible cIF New hormonal therapies hold promise by romoting mucosal growth and intestinal absorption and thereby leading to a consequent reduction in parenteral support and symptoms related to large stomal or faecal losses Outside the typical primary endpoints of cost data quality of life QoL is an important and yet underappreciated consideration of the effectiveness of targeted therapies In the clinical STEPS trial Jeppesen et al have previously shown a significant improvement of the SBS-QoL total score after 24 week treatment with teduglutide longitudinally but could not identify a statistical significance to the placebo group Accordingly Chen and colleagues carried out a post hoc analysis of the afore mentioned clinical trial data based on 86 patients and could confirm the results auf Jeppesen et al Taken together these clinical trial data did not show a direct benefit of teduglutide treatment on QoL in these patients while real life data on QoL changes are not available yet During the release of teduglutide in Germany the PNLiver trial DRKS00010993 recruited chronic intestinal failure patients with parenteral nutrition from 2014 till 2019 to evaluate the capability of non-invasive liver function tests in cIF patients in a cross-sectional n90 and longitudinal study n20 All participants underwent study visits including clinical examination dynamic liver function assessment comprehensive blood tests nutritional status assessment and quality of life assessment Short Form 36 SF-36 and SBS-QoL Therefore we have a comprehensive data set of a large monocentric cIF cohort prior to teduglutide treatment Consequently our unique QoL data from the PNLiver trail enables a followup assessment for an observation period above 24 weeks of patients who were in the meantime exposed to teduglutide in a real life setting Nevertheless QoL also tends to improve with longer duration on HPN Therefore we are aiming to extend the results with a pairwise matched control group from non teduglutide-treated PNLiver trail patients and collect follow-up data from this group accordingly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None