Purpose of this Study
In this study, people will be placed into one of two groups by chance. One group will receive two medicines, called romiplostim and prednisone. The other group will receive only prednisone, which is the usual treatment.
During the first part of the study, people in the study treatment group will receive weekly shots of romiplostim for up to 24 weeks and take prednisone for up to 8 weeks. People in the usual treatment group will take prednisone for up to 8 weeks. After 24 weeks, everyone will move to the second part of the study. The study treatment group may continue receiving romiplostim for up to one year, while the usual treatment group will not receive the study medicine.
Throughout the study, participants will visit the clinic for blood tests and physical exams so doctors can check their health and see how well the treatment is working.
Who Can Participate?
Eligibility
People can join this study if they have a blood condition called primary immune thrombocytopenia, also known as ITP. They must not have serious bleeding that threatens their life. Participants cannot have other autoimmune diseases, HIV, or hepatitis. They also cannot have had recent blood clots in a vein or artery. Researchers are studying new treatment options for people with ITP to learn if they can safely improve platelet counts and help control the disease.
Age Range
18-110
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 testing whether using two medicines together, called romiplostim and prednisone, works better than using prednisone alone for people who have a blood condition called primary immune thrombocytopenia. This condition causes low platelet levels, which can make it easier to bleed or bruise.
Researchers want to learn if the combination of romiplostim and prednisone can increase platelet counts more effectively than prednisone by itself. They also want to find out if taking both medicines together is safe and what side effects may occur.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP)
Principal Investigator
Ara
Metjian
Protocol Number
PRO00120637
NCT ID
NCT07700238
Phase
III
Enrollment Status
Pending Open to Enrollment