A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT07286032
Phase
PHASE3
Status
Recruiting

Conditions

  • Patients With Chemotherapy-Induced Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hetrombopag Olamine — DRUG
    For Part A, all participants would receive hetrombopag treatment.
  • Hetrombopag Olamine ;Hetrombopag Olamine Placebo — DRUG
    For Part B,participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

Study Details

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Key Dates

Start date
Apr 16, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Hetrombopag Olamine
  • Experimental: Part B:Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Primary Outcome Measure

Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. [ Time Frame: around 6 months. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90254
Arati Chand (PRINCIPAL_INVESTIGATOR)
AdventHealth Hematology and Oncology Denver Cypress Hematology and OncologyDenverColorado80210
Yousuf Gaffar (PRINCIPAL_INVESTIGATOR)
Oncology & Hematology Associates of West BrowardCoral SpringsFlorida33065
Sumit Sawhney (PRINCIPAL_INVESTIGATOR)
Mid-Florida Hematology & Oncology Centers, P.A.Orange CityFlorida32763
Santosh Nair (PRINCIPAL_INVESTIGATOR)
Springfield ClinicSpringfieldIllinois62702
Preet Singh (PRINCIPAL_INVESTIGATOR)
Morristown Medical CenterMorristownNew Jersey07039
Se young Han (PRINCIPAL_INVESTIGATOR)
New York Cancer and Blood Specialists One OncologyShirleyNew York11967
Richard Zuniga (PRINCIPAL_INVESTIGATOR)

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