The objective of ths study is to investigate whether use of Tranylcypromine, a monoamine oxidase inhibitor, results in increased expression of HbF in adults. If this is the case, we will use the results of this study to design follow-up research…
ID
Source
Brief title
Condition
- Haemoglobinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of HbF in peripheral blood. In adults the amount of HbF is normally
less than 1% of the total amount of hemoglobin. HbF levels should be increased
to at least 3% in order to use the results of this study for the design of a
follow-up study investigating the effect of Tranylcypromine on HbF levels in
sickle cell disease patients.
Secondary outcome
Not applicable.
Background summary
World-wide, the anemias are the most common hereditary disorders. The patients
have problems with hemoglobin, the most important protein in red blood cells.
The most common form of hereditary anemia is sickle cell disease. It is
estimated that there are around 600 patients with sickle cell disease in the
Rotterdam area alone. Before birth, humans express a special "baby" hemoglobin
called fetal hemoglobin (HbF). If the patients could replace their pathologic
adult sickle hemoglobin (HbS) by fully functional HbF, their conditon would
vastly improve. Currently, there are no pharmacological compounds known that
can efficiently reverse the switch from HbS to HbF. Recent research indicates
that Tranylcypromine may possess these properties. Some psychiatric patients
already take Tranylcypromine as part of their regular treatment. In this study
we wish to determine if these patients have increased HbF levels in their
peripheral blood. If we find that this is indeed the case, we will investigate
next whether Tranylcypromine could be given to sickle cell patients to increase
HbF levels. These follow-up investigations are not part of the current study.
Study objective
The objective of ths study is to investigate whether use of Tranylcypromine, a
monoamine oxidase inhibitor, results in increased expression of HbF in adults.
If this is the case, we will use the results of this study to design follow-up
research investigating whether use of Tranylcypromine also results in increased
HbF levels in sickle cell disease patients.
Study design
From the subjects (n=10), a maximum of 10 ml of peripheral blood will be
collected through venipuncture, for a maximum of 2 times. This will be used to
determine the amount of HbF, both at the protein and the mRNA level. Left-over
material will be stored frozen so the analysis can be repeated when needed,
without the requirement for collecting a fresh blood sample.
Study burden and risks
Burden: donation of a maximum of 2 blood samples with a maximum volume of 10 ml
each, through venipuncture. Risk: nausea and/or fainting in case of hemophobia.
Patients with known hemophobia are excluded from participating in this study.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Adult patients who give consent, taking Tranylcypromine for 2 months or longer, prescribed by their attending physician as part of their regular treatment.
Exclusion criteria
Non-compliance; hemophobia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47963.078.14 |