Purpose of this Study
If you join this study, you may receive a study medicine called HRX215 or a placebo, which looks the same but has no medicine in it. You will be placed into one of these two groups by chance, like picking a name from a hat. You have an equal chance of getting either one. If you are placed into a group by chance, neither you nor your study doctor will know which drug you are receiving.
Who Can Participate?
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to learn if a new medicine called HRX215 is safe and helpful for people who need surgery to remove part of the liver because of colon cancer that has spread to the liver. Surgery to remove the liver tumor is the best treatment to help people live longer. For the surgery to work well, enough healthy liver must be left behind. HRX215 was created to help the liver heal and grow back faster after surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Double-blind, randomized, placebo-controlled, study to evaluate the safety and efficacy of HRX215 in participants after major hepatectomy, preceded by two open pilot parts in participants after minor and after major hepatectomy due to colon carcinoma metastases
Principal Investigator
Michael
Lidsky
Protocol Number
PRO00119835
Phase
I/II
Enrollment Status
Pending Open to Enrollment