Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-06

Study Completion Date

2023-02-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

NCT05864014

Chemotherapy-Induced Thrombocytopenia

ACTIVE_NOT_RECRUITING PHASE3

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

NCT07286032

Patients With Chemotherapy-Induced Thrombocytopenia

NOT_YET_RECRUITING PHASE3

Herombopag for Chemotherapy-induced Thrombocytopenia

NCT05236582

Chemotherapy-induced Thrombocytopenia Herombopag

RECRUITING PHASE2

Eltrombopag for Chemotherapy-induced Thrombocytopenia

NCT04600960

Chemotherapy-induced Thrombocytopenia Eltrombopag

RECRUITING PHASE2

A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

NCT05261646

Chemotherapy-Induced Thrombocytopenia

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-Induced Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Hetrombopag compared with placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A：Hetrombopag

Group Type EXPERIMENTAL

Hetrombopag

Intervention Type DRUG

Hetrombopag

Group B：Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hetrombopag

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Men and women, 18-75 years of age;
2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;

Exclusion Criteria

1. Screening and baseline platelet count\< 30×109/L;
2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
4. Participant has serious bleeding symptoms;
5. Participant has no hepatic metastases, ALT/AST\>3ULN, TBIL\>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
6. Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
7. History of allergy to the study drug;
8. Participant with HIV;
9. Pregnant or lactating women;
10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No