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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia
EU CTIS ID: 2023-505232-36-00
What this study is testing
1-. To compare bomedemstat to hydroxyurea with respect to DCHR.
- Therapeutic confirmatory (Phase III)
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
- Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and in indication for cytoreductive therapy regardless of age or risk status.
- Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis.
- Has received no prior cytoreductive treatment for their ET.
- Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable.
You likely can't join if
- History of any illness/impairment of gastrointestinal function that might interfere with drug absorption.
- History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has an active infection requiring systemic therapy.
- Has had a major surgery <4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery >4 weeks prior to first dose.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Taiwan
- Colombia
- Australia
- United Kingdom
- Mexico
- Japan
- Israel
- Turkey
- China
- Hong Kong
- Canada
- Argentina
- Chile
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Taiwan; Colombia; Australia; United Kingdom; Mexico and 8 more location(s). 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.