Back to resultsHetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
Primary Purpose
Chemotherapy-Induced Thrombocytopenia
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hetrombopag
Hetrombopag plus Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-Induced Thrombocytopenia
Eligibility Criteria
Inclusion Criteria: Men and women, 18-75 years of age; Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents; Participant experienced thrombocytopenia and chemotherapy delay; ECOG performance status 0-1; 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); Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault） Exclusion Criteria: Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; Participant has serious bleeding symptoms; History of allergy to the study drug; Participant with HIV; Pregnant or lactating women; Participant has received any experimental therapy within 4 weeks prior to screening Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Hetrombopag
Hetrombopag plus Placebo
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The proportion of treatment responders.
Secondary Outcome Measures
Duration from the commencement of treatment to a platelet count ≥100×109/L;
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
Proportion of subjects without serious bleeding events;
Number of adverse events (AEs)/serious adverse events (SAEs)
Full Information
NCT ID
NCT05864014
First Posted
May 9, 2023
Last Updated
May 17, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05864014
Brief Title
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
Official Title
Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hetrombopag
Arm Type
Experimental
Arm Title
Hetrombopag plus Placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hetrombopag
Intervention Description
Hetrombopag
Intervention Type
Drug
Intervention Name(s)
Hetrombopag plus Placebo
Intervention Description
Hetrombopag plus Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The proportion of treatment responders.
Time Frame
Randomization up to 80 days
Secondary Outcome Measure Information:
Title
Duration from the commencement of treatment to a platelet count ≥100×109/L;
Time Frame
Randomization up to 30 days
Title
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
Time Frame
Randomization up to 160 days
Title
Proportion of subjects without serious bleeding events;
Time Frame
Randomization up to 190 days
Title
Number of adverse events (AEs)/serious adverse events (SAEs)
Time Frame
Randomization up to 190 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, 18-75 years of age;
Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
Participant experienced thrombocytopenia and chemotherapy delay;
ECOG performance status 0-1;
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);
Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）
Exclusion Criteria:
Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
Participant has serious bleeding symptoms;
History of allergy to the study drug;
Participant with HIV;
Pregnant or lactating women;
Participant has received any experimental therapy within 4 weeks prior to screening
Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Tang
Phone
+86 177 2128 6353
Email
Qian.tang@hengrui.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
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