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

NCT05864014 | Active Not Recruiting Phase 3

• 1 other identifier: SHR8735-301
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The proportion of treatment responders.

  Randomization up to 80 days

Secondary Outcomes (4)

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

  Randomization up to 30 days

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

  Randomization up to 160 days

• Proportion of subjects without serious bleeding events;

  Randomization up to 190 days

• Number of adverse events (AEs)/serious adverse events (SAEs)

  Randomization up to 190 days

Study Arms (3)

Hetrombopag

EXPERIMENTAL

Drug: Hetrombopag

Hetrombopag plus Placebo

EXPERIMENTAL

Drug: Hetrombopag plus Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hetrombopag DRUG

Hetrombopag

Hetrombopag

Hetrombopag plus Placebo DRUG

Hetrombopag plus Placebo

Hetrombopag plus Placebo

Placebo DRUG

Placebo

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 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）

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Hematology Tumor Research Center of Harbin First Hospital

Haerbin, Heilongjiang, 150000, China

Location

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

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: April 25, 2023
• Primary Completion: March 3, 2025
• Study Completion: September 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)