Clinical trial · Interventional
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag in Subjects With Chemotherapy-induced Thrombocytopenia Receiving Chemotherapy for the Treatment of Solid Tumors.
NCT03976882CI-TRIAL-00089844completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hetrombopag | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A:Hetrombopag
- interventionNames
- Drug: Hetrombopag
- type
- PLACEBO_COMPARATOR
- label
- Group B:Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The proportion of treatment responders.
- timeFrame
- Randomization up to 90 days
Secondary outcomes (4)
- measure
- Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women, 18-75 years of age; 2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen; 3. Participant experienced thrombocytopenia and chemotherapy delay; 4. ECOG performance status 0-1; Exclusion Criteria: 1. Screening and baseline platelet count\< 30×109/L; 2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening; 3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 4. Participant has serious bleeding symptoms; 5. Participant has no hepatic metastases, ALT/AST\>3ULN, TBIL\>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN; 6. Blood Cr≥1.5ULN or eGFR≤60 ml/min(Cockcroft-Gault); 7. History of allergy to the study drug; 8. Participant with HIV; 9. Pregnant or lactating women; 10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
References
Publications (1)
- DERIVEDQin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024. PMID 38882443