Back to resultsHetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
Primary Purpose
Chemotherapy-Induced Thrombocytopenia
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hetrombopag
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 confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
- Participant experienced thrombocytopenia and chemotherapy delay;
- ECOG performance status 0-1;
Exclusion Criteria:
- Screening and baseline platelet count< 30×109/L;
- Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
- Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
- Participant has serious bleeding symptoms;
- Participant has no hepatic metastases, ALT/AST>3ULN, TBIL>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
- Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
- History of allergy to the study drug;
- Participant with HIV;
- Pregnant or lactating women;
- Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Sites / Locations
- Najing Bayi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A：Hetrombopag
Group B：Placebo
Arm Description
Outcomes
Primary Outcome Measures
The proportion of treatment responders.
Secondary Outcome Measures
Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L
Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification
Proportion of subjects without serious bleeding event
Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0
Full Information
NCT ID
NCT03976882
First Posted
June 3, 2019
Last Updated
September 1, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03976882
Brief Title
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 15, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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
Model Description
Hetrombopag compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A：Hetrombopag
Arm Type
Experimental
Arm Title
Group B：Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hetrombopag
Intervention Description
Hetrombopag
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 90 days
Secondary Outcome Measure Information:
Title
Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L
Time Frame
Randomization up to 30 days
Title
Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification
Time Frame
Randomization up to 150 days
Title
Proportion of subjects without serious bleeding event
Time Frame
Randomization up to 180 days
Title
Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0
Time Frame
Randomization up to 180 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 confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
Participant experienced thrombocytopenia and chemotherapy delay;
ECOG performance status 0-1;
Exclusion Criteria:
Screening and baseline platelet count< 30×109/L;
Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
Participant has serious bleeding symptoms;
Participant has no hepatic metastases, ALT/AST>3ULN, TBIL>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
History of allergy to the study drug;
Participant with HIV;
Pregnant or lactating women;
Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Facility Information:
Facility Name
Najing Bayi Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
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