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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05864014
Collaborator
(none)
192
Enrollment
3
Arms
16.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hetrombopag

Drug: Hetrombopag
Hetrombopag
Experimental: Hetrombopag plus Placebo

Drug: Hetrombopag plus Placebo
Hetrombopag plus Placebo
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. The proportion of treatment responders. [Randomization up to 80 days]

Secondary Outcome Measures

  1. Duration from the commencement of treatment to a platelet count ≥100×109/L; [Randomization up to 30 days]

  2. Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and; [Randomization up to 160 days]

  3. Proportion of subjects without serious bleeding events; [Randomization up to 190 days]

  4. Number of adverse events (AEs)/serious adverse events (SAEs) [Randomization up to 190 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05864014
Other Study ID Numbers:
  • SHR8735-301
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombocytopenia

Study Results

No Results Posted as of May 18, 2023