Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638502
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Safety of HRX215 in Patients After Minor and Major Liver Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double Blind Randomized Placebo Controlled Study to Evaluate the Safety of HRX215 in Patients Post Major Hepatectomy Preceded by an Open Pilot Phase in Patients Post Minor Hepatectomy Due to Metastases of a Colon Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumors due to colorectal carcinoma in the liver
The main question it aims to answer are
1 to learn about the safety of HRX215
2 to learn about how the body absorbs distributes and gets rid of HRX215 Researchers will compare HRX215 to a placebo a look-alike substance that contains no drug to see what medical problems participants have when taking HRX215
Participants will
Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days Clinic visits every two weeks for the next two visits The visit at two weeks may be a home visit or clinic visit Additional clinic visits 3 months and 6 months after the start of treatment
The main question it aims to answer are
1 to learn about the safety of HRX215
2 to learn about how the body absorbs distributes and gets rid of HRX215 Researchers will compare HRX215 to a placebo a look-alike substance that contains no drug to see what medical problems participants have when taking HRX215
Participants will
Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days Clinic visits every two weeks for the next two visits The visit at two weeks may be a home visit or clinic visit Additional clinic visits 3 months and 6 months after the start of treatment
Detailed Description:
The study is designed to evaluate primarily the safety of HRX215 first after minor liver resection and when safety is established in those patients after major liver resection Participants will start treatment within 1-3 days after liver resection and will receive 28 day treatment with HRX215 twice daily or placebo with follow up visits 3 and 6 months after completion of treatment
The pharmacokinetics will be compared with the results of the phase I studies whereas efficacy will be evaluated only descriptively Secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the ICU and 90 day mortality in participants who receive treatment with HRX215 vs placebo
The pharmacokinetics will be compared with the results of the phase I studies whereas efficacy will be evaluated only descriptively Secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the ICU and 90 day mortality in participants who receive treatment with HRX215 vs placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None