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

NCT03976882 | Completed Phase 3 FDA Drug

• 1 other identifier: HR-TPO-CIT-III
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The proportion of treatment responders.

  Randomization up to 90 days

Secondary Outcomes (4)

• Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L

  Randomization up to 30 days

• Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification

  Randomization up to 150 days

• Proportion of subjects without serious bleeding event

  Randomization up to 180 days

• 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

  Randomization up to 180 days

Study Arms (2)

Group A：Hetrombopag

EXPERIMENTAL

Drug: Hetrombopag

Group B：Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hetrombopag DRUG

Hetrombopag

Group A：Hetrombopag

Placebo DRUG

Placebo

Group B：Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Najing Bayi Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.

  PMID: 38882443 DERIVED

MeSH Terms

Interventions

hetrombopag

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Hetrombopag compared with placebo

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: November 6, 2019
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)