Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-14
Brief Title:
Semaglutide in Auto-HSCT
Sponsor:
Klaus Gottlob Müller
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PROTECT
Brief Summary:
The primary objective of this clinical trial is to ievaluate the effect of semaglutide GLP-1 receptor agonist in reducing intensity of gastrointestinal GI mucositis in patients undergoing high-dosage chemotherapy followed by autologous auto haematopoietic stem cell transplantation HSCT The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT
Study design
The study is designed as a randomized double-blind placebo-controlled phase 2 two-centre investigator-initiated clinical study
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 11 manner to receive either semaglutide or placebo The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously sc 025 mg once-weekly QW prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 05 mg QW Total duration of treatment with investigational drug will be 8 weeks Total study duration for the individual patients will be 20-22 weeks including a 2-4-week screening period and 10 weeks of follow-up
Study population
A planned total number of 40 patients will be randomized
Study design
The study is designed as a randomized double-blind placebo-controlled phase 2 two-centre investigator-initiated clinical study
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 11 manner to receive either semaglutide or placebo The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously sc 025 mg once-weekly QW prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 05 mg QW Total duration of treatment with investigational drug will be 8 weeks Total study duration for the individual patients will be 20-22 weeks including a 2-4-week screening period and 10 weeks of follow-up
Study population
A planned total number of 40 patients will be randomized
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502139-20-00 | CTIS | None | None |