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

NCT ID: NCT07286032

Last Updated: 2025-12-16

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2029-06-30

Brief Summary

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

Detailed Description

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Conditions

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Patients With Chemotherapy-Induced Thrombocytopenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Hetrombopag Olamine

Group Type EXPERIMENTAL

Hetrombopag Olamine

Intervention Type DRUG

For Part A, all participants would receive hetrombopag treatment.

Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Group Type EXPERIMENTAL

Hetrombopag Olamine ；Hetrombopag Olamine Placebo

Intervention Type DRUG

For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

Interventions

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Hetrombopag Olamine

For Part A, all participants would receive hetrombopag treatment.

Intervention Type DRUG

Hetrombopag Olamine ；Hetrombopag Olamine Placebo

For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female gender, age ≥18 years at screening.
2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
5. Life expectancy ≥6 months.
6. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria

1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
2. Hematologic malignancies.
3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
4. Untreated brain metastases; or with leptomeningeal metastasis.
5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
6. Severe cardiovascular disorders or interventions within 6 months
7. Have arterial/venous thrombosis within 6 months
8. Known bleeding disorders, platelet dysfunction
9. Severe haemorrhage during screening
10. Acute or uncontrolled hepatitis B\&C infection
11. Human immunodeficiency virus (HIV) infection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Junye Xiong

Role: CONTACT

[email protected]
0518-82342973

Other Identifiers

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SHR8735-303

Identifier Type: -

Identifier Source: org_study_id