RUBY 4 - An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias
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TREATT: Trial to EvaluAte Tranexamic acid therapy in Thrombocytopenia
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RUBY 4 - An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias
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RUBY 4 - An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias
Treatment stage
Multiple stages
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Subtype
ITP
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Treatment stage
First line
1
Treatment stage
Multiple stages
2
Subtype
Thrombocytopenia
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Treatment stage
Multiple stages
1
Subtype
Warm autoimmune hemolytic anemia
Count1
Treatment stage
Multiple stages
1
Subtype
Cold agglutinin disease
Count1
Treatment stage
Multiple stages
1
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Population
Description
ECOG
PI - Evelina
PI - KCH
PI - GSTT
PI - PRUH
PI - QEH
PI - UHL
Trial summary
Key Eligibility Criteria
Summary
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Summary
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
Benjamin, R.
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis
Inclusion for Arm 1:
For adults with newly diagnosed ITP
Open-label randomised study: romiplostim plus dexamethasone vs dexamethasone
Not specified
Gulnaz.Shah@gstt.nhs.uk
Primary immune thrombocytopenia (ITP) is an acquired disease that causes thrombocytopenia through an immunological mechanism. The estimated incidence of ITP is around 2-6 per 100,000 children/year and approximately 2-4 per 100,000 adults/year. The primary manifestation of ITP is an increased tendency to bleed, which varies from cutaneous purpura to more severe mucosal bleeding. ITP is characterized by a low circulating platelet counts (<100×109/L) caused by platelet destruction and diminished pl
18 years of age at the time of signing informed consent.
For adults with ITP
Research database and biobank
Not specified
Kumar, T
Kumar, T
The UK Adult ITP Registry aims to collect clinical data (co-morbid conditions, ITP-specific treatments, laboratory results, and bleeding events) and biological samples (whole blood [15 mL, ~EDTA] or saliva [Oragene saliva kit])on adult patients with primary immune thrombocytopenia (ITP) in an effort to investigate outstanding questions in disease progression, treatment effectiveness, and co-morbid burden. An overview of our study protocol may be found in the document “UKITP Study Protocol 2.1” o
Adult patients (18 years) diagnosed with primary immune thrombocytopenia (ITP) as defined by
For adult patients with autoimmune cytopenias
Open-label study of Povetacicept
Not specified
Gulnaz.Shah@gstt.nhs.uk
An autoimmune disease occurs when the immune system mistakenly recognizes healthy parts of the body as foreign and attacks them. Cytopenia is a condition characterized by a low number of cells in the blood. In autoimmune cytopenias, a type of white blood cell called a plasma cell begins producing antibodies that attack the body's own platelets or red blood cells, resulting in illness. Various types of autoimmune cytopenias exist, including idiopathic thrombocytopenia (ITP), warm autoimmune hemol
For adults with any haematological malignancy expected to thrombocytopenia for >4 days
Randomised trial: Tranexamic acid in patients with severe thrombocytopenia
Not specified
Floro, L
Patients with cancers of the blood often develop low blood cell counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). But recent studies have indicated that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is a type of drug th
At least 18 years of age
For adult patients with autoimmune cytopenias
Open-label study of Povetacicept
Not specified
Gulnaz.Shah@gstt.nhs.uk
An autoimmune disease occurs when the immune system mistakenly recognizes healthy parts of the body as foreign and attacks them. Cytopenia is a condition characterized by a low number of cells in the blood. In autoimmune cytopenias, a type of white blood cell called a plasma cell begins producing antibodies that attack the body's own platelets or red blood cells, resulting in illness. Various types of autoimmune cytopenias exist, including idiopathic thrombocytopenia (ITP), warm autoimmune hemol
For adult patients with autoimmune cytopenias
Open-label study of Povetacicept
Not specified
Gulnaz.Shah@gstt.nhs.uk
An autoimmune disease occurs when the immune system mistakenly recognizes healthy parts of the body as foreign and attacks them. Cytopenia is a condition characterized by a low number of cells in the blood. In autoimmune cytopenias, a type of white blood cell called a plasma cell begins producing antibodies that attack the body's own platelets or red blood cells, resulting in illness. Various types of autoimmune cytopenias exist, including idiopathic thrombocytopenia (ITP), warm autoimmune hemol