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Trial Title:
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
NCT ID:
NCT05864014
Condition:
Chemotherapy-Induced Thrombocytopenia
Conditions: Official terms:
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Hetrombopag
Description:
Hetrombopag
Arm group label:
Hetrombopag
Intervention type:
Drug
Intervention name:
Hetrombopag plus Placebo
Description:
Hetrombopag plus Placebo
Arm group label:
Hetrombopag plus Placebo
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
Summary:
The purpose of current study is to evaluate the efficacy and safety of hetrombopag for
the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men and women, 18-75 years of age;
2. Participant with a histologically or cytologically confirmed solid tumor receiving
treatment with chemotherapeutic agents;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;
5. Adequate Liver function; aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0
x ULN for participant with liver metastases);
6. Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60
ml/min（Cockcroft-Gault）
Exclusion Criteria:
1. Participant has any history of hematologic diseases other than chemotherapy-induced
thrombocytopenia;
2. Participant has serious bleeding symptoms;
3. History of allergy to the study drug;
4. Participant with HIV;
5. Pregnant or lactating women;
6. Participant has received any experimental therapy within 4 weeks prior to screening
7. Other conditions that may affect participant's safety or trial evaluations per
investigator's discretion
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05864014
