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Completed

NCT Number: NCT03976882

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

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.

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Key information

Conditions

Chemotherapy-Induced Thrombocytopenia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Najing Bayi Hospital

Nanjing, Jiangsu, 210002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hetrombopag

Drug

Hetrombopag

Placebo

Drug

Placebo

Primary outcomes

  1. The proportion of treatment responders.

    Time frame: Randomization up to 90 days

Secondary outcomes

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

    Time frame: Randomization up to 30 days

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

    Time frame: Randomization up to 150 days

  3. Proportion of subjects without serious bleeding event

    Time frame: Randomization up to 180 days

  4. 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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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