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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chemotherapy-Induced Thrombocytopenia
• Intervention / Treatment: Drug: Placebo; Drug: Hetrombopag

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Najing Bayi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A：Hetrombopag	Drug: Hetrombopag; Hetrombopag
Placebo Comparator: Group B：Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of treatment responders.	Randomization up to 90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: HR-TPO-CIT-III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No