Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

NCT05575986 | Unknown Phase 4

• 1 other identifier: HR-OBU-HuB-CA-II-019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Tumors of the Digestive System; Trombocitopenia

Outcome Measures

Primary Outcomes (1)

• Days required for platelet recovery to ≥75×10^9/ L

  Days required for platelet recovery to ≥75×10\^9/ L

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (2)

• The lowest platelet count

  At the end of Cycle 2 (each cycle is 28 days)

• Safety of treatment

  2 Cycle (each cycle is 28 days)

Study Arms (1)

Observation group

EXPERIMENTAL

Herombopag Olamine Tablets

Drug: Hetrombopag Olamine

Interventions

Hetrombopag Olamine DRUG

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.

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

xianglin Yuan

Wuhan, Hubei, 430000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 12, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)