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A Phase 3 study of Hetrombopag in patients with low blood platelet count (thrombocytopenia) caused by chemotherapy
EU CTIS ID: 2025-524209-34-00
What this study is testing
Part A To evaluate the pharmacokinetic (PK) characteristics of hetrombopag in non-Asian participants with chemotherapy-induced thrombocytopenia (CIT). Part B To evaluate the efficacy of hetrombopag treatment in participants with CIT.
- 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
- Male or female gender, age ≥18 years at screening.
- Histologically or cytologically confirmed solid tumor
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- PC < 75×109/L at enrollment.
- Experiencing a protocol-defined treatment delay of ≥7 days per chemotherapy cycle due to CIT with PC <75×109/L (Part B only).
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
You likely can't join if
- PC <25×109/L at screening.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies
- Untreated brain metastases; or with leptomeningeal metastasis.
- Bone marrow involvement or bone marrow metastasis on routine imaging.
- Have arterial/venous thrombosis within 6 months prior to Study Day 1
See the full eligibility criteria
- Male or female gender, age ≥18 years at screening.
- Histologically or cytologically confirmed solid tumor
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- PC < 75×109/L at enrollment.
- Experiencing a protocol-defined treatment delay of ≥7 days per chemotherapy cycle due to CIT with PC <75×109/L (Part B only).
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Adequate organ and hematologic function
- Having non-Asian race and ethnicity (Part A only).
- PC <25×109/L at screening.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies
- Untreated brain metastases; or with leptomeningeal metastasis.
- Bone marrow involvement or bone marrow metastasis on routine imaging.
- Have arterial/venous thrombosis within 6 months prior to Study Day 1
- Severe hemorrhage (e.g., gastrointestinal, or intracranial hemorrhage) within 28 days prior to Study Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United States
- Canada
- Australia
- Korea, Republic of
- United Kingdom
- Ukraine
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 Argentina; United States; Canada; Australia; Korea, Republic of; United Kingdom and 1 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.