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

May 17, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women, 18-75 years of age;
  2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
  3. Participant experienced thrombocytopenia and chemotherapy delay;
  4. ECOG performance status 0-1;
  5. 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);
  6. Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Hetrombopag
Drug: Hetrombopag
Hetrombopag
Experimental: Hetrombopag plus Placebo
Drug: Hetrombopag plus Placebo
Hetrombopag plus Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of treatment responders.
Time Frame: Randomization up to 80 days
Randomization up to 80 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration from the commencement of treatment to a platelet count ≥100×109/L;
Time Frame: Randomization up to 30 days
Randomization up to 30 days
Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
Time Frame: Randomization up to 160 days
Randomization up to 160 days
Proportion of subjects without serious bleeding events;
Time Frame: Randomization up to 190 days
Randomization up to 190 days
Number of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: Randomization up to 190 days
Randomization up to 190 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR8735-301

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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