Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05864014

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

The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Chemotherapy-Induced Thrombocytopenia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hematology Tumor Research Center of Harbin First Hospital

Haerbin, Heilongjiang, 150000, 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 histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
  • Participant experienced thrombocytopenia and chemotherapy delay;
  • ECOG performance status 0-1;
  • Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
  • Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion criteria

  • Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
  • Participant has serious bleeding symptoms;
  • History of allergy to the study drug;
  • Participant with HIV;
  • Pregnant or lactating women;
  • Participant has received any experimental therapy within 4 weeks prior to screening
  • Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Treatment and study plan

hetrombopag

Drug

Hetrombopag

Hetrombopag plus Placebo

Drug

Hetrombopag plus Placebo

Placebo

Drug

Placebo

Primary outcomes

  1. The proportion of treatment responders.

    Time frame: Randomization up to 80 days

Secondary outcomes

  1. Duration from the commencement of treatment to a platelet count ≥100×109/L;

    Time frame: Randomization up to 30 days

  2. Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;

    Time frame: Randomization up to 160 days

  3. Proportion of subjects without serious bleeding events;

    Time frame: Randomization up to 190 days

  4. Number of adverse events (AEs)/serious adverse events (SAEs)

    Time frame: Randomization up to 190 days

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2023
Registry last updated
Apr 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.