hetrombopag: Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05575986

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors

Condition or Disease	Intervention/Treatment	Phase
Malignant Tumors of the Digestive System Trombocitopenia	Drug: Hetrombopag Olamine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Observation group Herombopag Olamine Tablets	Drug: Hetrombopag Olamine Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals.

Arm

Intervention/Treatment

Experimental: Observation group

Herombopag Olamine Tablets

Drug: Hetrombopag Olamine

Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals.

Outcome Measures

Primary Outcome Measures

Days required for platelet recovery to ≥75×10^9/ L [At the end of Cycle 1 (each cycle is 28 days)]
Days required for platelet recovery to ≥75×10^9/ L

Secondary Outcome Measures

The lowest platelet count [At the end of Cycle 2 (each cycle is 28 days)]
The lowest platelet count
Safety of treatment [2 Cycle (each cycle is 28 days)]
Measure of time from study enrollment until progression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Volunteer to participate in clinical research and sign informed consent;
Age ≥18 years;
Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L;
At least 10 days between TPO, IL-11 or platelet transfusion;
ECOG 0 to 2 points;
Expected survival time > 3 months;
Sufficient organ function for subsequent chemotherapy;
Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.

Exclusion Criteria:

Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding;
Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
Clinically significant acute or active bleeding within the week prior to screening;
Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting);
Subjects had a history of arterial or venous thrombosis within 3 months before screening;
Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
The subject has a history of chronic platelet or hemorrhagic disorders, or thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune thrombocytopenic purpura);
TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
Those who cannot be treated with oral drugs;
Allergic to hetrombopag or any excipient;
Those whose organ function could not tolerate further antitumor therapy as assessed by the investigator; This product is not recommended for use or discontinuation of treatment in patients who meet any of the following criteria for liver function

ALT and AST > 8 x ULN.

ALT or AST>5×ULN for 2 weeks;

ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5);

ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or tenderness, fever, rash, and/or eosinophilia (>5%).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	xianglin Yuan	Wuhan	Hubei	China	430000

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xianglin Yuan, Chief physician, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05575986

Other Study ID Numbers:

HR-OBU-HuB-CA-II-019

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 12, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Digestive System Neoplasms

Gastrointestinal Neoplasms

Thrombocytopenia

Study Results

No Results Posted as of Oct 12, 2022