The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,
fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by
mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid
reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media,
local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis
patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms
of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs.
There is currently no specific treatment for this disease with the exception of rare cases.
There are, however, some case reports suggesting that omalizumab might decrease symptoms
including hypotensive events.
The aim of the study is to investigate whether patients suffering from mastocytosis benefit
from a 6 month course of omalizumab with regard to symptoms and quality of life and whether
the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the
efficacy of omalizumab in patients with mastocytosis.
- Trial with medicinal product