Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03562130
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2018-05-18
Brief Title:
Characterization of the Long-term Safety Efficacy and Pharmacodynamics Revestive in the Management of Short Bowel Syndrome Pediatric Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Monocentric Single-arm Study to Characterize the Long-term Safety Efficacy and Pharmacodynamic of GLP-2 Analog Revestive in the Management of Short Bowel Syndrome Pediatric Patients on Home-parenteral Nutrition HPN
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
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:
REVE
Brief Summary:
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption minimize the inconvenience of diarrhea and avoid reduce or eliminate the need for parenteral support PS to achieve normal growth to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient
Detailed Description:
The short bowel syndrome SBS may be defined as a severe malabsorption caused by reduction of intestinal absorptive surface following massive resection of the small intestine Teduglutide Revestive is an analog of glucagon-like peptide 2 GLP-2 a naturally occurring hormone that regulates the functional and structural integrity of the cells lining the gastrointestinal tract The aim of the treatment is to maximize intestinal absorption minimize the inconvenience of diarrhea and avoid reduce or eliminate the need for parenteral support PS to achieve the best possible quality of life for the patient The rationale for the use of Revestive is based on data obtained especially in the trial in SBS patients
Treatment with 005 mgkgday was safe and well tolerated no recorded side effects
Patients remained stable despite substantial reduction in parenteral nutrition PN supply as evidenced by stable body weight and height serum electrolytes pancreatic enzymes and renal function tests
Treatment was associated with
Reduced PN volume and calories delivered by 25 and 45 respectively with 20 of patients weaned off PN during the study period
Increased Enteral Nutrition EN supply in volume and calories by 40 and 62 respectively
Increased in plasma citrulline during the treatment period but decreased after Teduglutide discontinuation The recommended dose of Revestive in children and adolescents aged 1 to 17 years is the same as for adults 005 mgkg body weight once daily
Treatment with 005 mgkgday was safe and well tolerated no recorded side effects
Patients remained stable despite substantial reduction in parenteral nutrition PN supply as evidenced by stable body weight and height serum electrolytes pancreatic enzymes and renal function tests
Treatment was associated with
Reduced PN volume and calories delivered by 25 and 45 respectively with 20 of patients weaned off PN during the study period
Increased Enteral Nutrition EN supply in volume and calories by 40 and 62 respectively
Increased in plasma citrulline during the treatment period but decreased after Teduglutide discontinuation The recommended dose of Revestive in children and adolescents aged 1 to 17 years is the same as for adults 005 mgkg body weight once daily
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001405-32 | EUDRACT_NUMBER | None | None |