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A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
EU CTIS ID: 2023-509397-39-00
What this study is testing
Part A: To characterize the safety and tolerability of up to four dose levels of rilzabrutinib in patients with ITP Part A: To explore the clinical activity of up to four dose levels of rilzabrutinib in relapsed/refractory patients with ITP Part B: To characterize the safety and tolerability of 400 mg BID dose of rilzabrutinib in patients with ITP Part B: To further explore the clinical activity and durability of response of the selected dose of 400 mg BID of rilzabrutinib in patients with ITP who have relapsed or have an insufficient response to prior therapies Part B: To evaluate the platelet response to rilzabrutinib therapy in the first 8 weeks of active treatment for the achievement of the primary endpoint
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients, aged 18 to 80 years old
- Immune-related ITP (both primary and secondary)
You likely can't join if
- Pregnant or lactating women
- Current drug or alcohol abuse
- History of solid organ transplant
- Positive screening for HIV, hepatitis B, or hepatitis C
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.