Hetrombopag plus Placebo: Hetrombopag plus Placebo
Placebo: Placebo
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The proportion of treatment responders. — Randomization up to 80 days
Trial sites (1)
Facility
City
Region
Status
Hematology Tumor Research Center of Harbin First Hospital
Haerbin
Heilongjiang
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.