Purpura, Thrombocytopaenic, Idiopathic Clinical Trial
Official title:
A Clinical and Mechanistic Proof of Efficacy Study With Belimumab in Chronic Immune Thrombocytopenia (ITP) Patients.
Chronic immune thrombocytopenia (ITP) is a longterm disease in which the blood does not clot
normally. This is due to a low number of blood cell fragments called platelets. Platelets
clot to seal small cuts or breaks on blood vessel walls and stop bleeding. Normally the
immune system makes proteins called antibodies to fight off harmful substances that enter
the body. In ITP, the immune system produces antibodies that attack and destroy the body's
platelets by mistake.
Patients can suffer from bleeding under the skin, nosebleeds, blood in urine or stools and
in very severe cases bleeding in the brain. Patients have an increased frequency of death
from bleeding complications compared to normal.
Chronic ITP is fairly rare , with an incidence of 32 new cases/million people each year.
Existing treatments work by lowering the activity of the immune system or directly
increasing platelet count. These treatments do not work effectively in all patients and can
have side effects. We hope that understanding how belimumab works in ITP will help in the
development of future treatments for ITP and other autoimmune diseases.
We will test the safety, blood levels and effects of the study medication in people with
chronic ITP. Patients will receive the study medication intravenously (through a needle
inserted into a vein) and blood samples will be taken before and on several occasions
afterwards.
Up to 40 patients with chronic ITP, aged 18 to 75 will participate. Approximately 11
patients will take dummy medicine instead of the study medicine neither they or their study
doctor will know which one they are given. Participants will take up to 57 weeks to finish
the study. They'll make 12 outpatient visits.
The study will take place in hospitals in the UK. Other sites in mainland Europe may also be
initiated.
A pharmaceutical company, GlaxoSmithKline, is funding the study.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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