Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

NCT05442632 | Recruiting Phase 2

• 1 other identifier: OBU-SH-HCC-II-010
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

Conditions

Hepatopathy

Keywords

Hepatopathy; thrombocytopenia; Hetrombopag

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period

  Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.

  From the start of using the investigational drug to 7 days after surgery completion

Secondary Outcomes (5)

• Proportion of patients with bleeding after surgery need intervention.

  up to 7 days following surgery。

• Changes in preoperative Platelet count compared to baseline

  baseline and up to 1 days prior to surgery

• Proportion of patients whose Platelet count returned to ≥80×10^9/L

  baseline and up to 1 days prior to surgery

• Incidence of deep venous thrombosis

  up to 3 months following surgery.

• Incidence of liver failure

  up to 3 months following surgery.

Study Arms (2)

Experimental: 1

EXPERIMENTAL

durg：Hetrombopag 5mg，once daily，oral

Drug: Hetrombopag

Experimental: 2

EXPERIMENTAL

Ndurg： Placebo 5mg，once daily，oral

Drug: Placebo

Interventions

Hetrombopag DRUG

The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Experimental: 1

Placebo DRUG

The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Experimental: 2

Eligibility Criteria

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

You may qualify if:

• \. Male and female subjects ≥18 years of age；
• Patients prepared to receive hepatectomy；
• ×10\^9/L≤platelet count≤80×10\^9/L；
• Child-PUgh score A or grade B (≤7 )；
• Life expectancy ≥3 months；
• Normal Bone marrow hematopoiesis and renal function;
• Voluntary participation and written informed consent;

You may not qualify if:

• Central nervous system diseases caused by liver disease;
• Platelet transfusion within 7 days prior to the first dose of study drug;
• History of any primary hematologic disorder;
• History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
• Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
• History of Myelodysplastic Syndrome (MDS);
• Those with bleeding tendency，have evidence of hereditary bleeding or blood coagulation disorder;
• Females who are pregnant (positive β-hCG test ) or breastfeeding;
• Subjects who have participated in another investigational trial within 30 days prior to Visit 1;
• Those with uncontrollable neurological and psychiatric diseases or mental disorders, poor compliance, unable to cooperate and describe treatment response;
• Subjects with known intolerance or allergy to any of the ingredients in eltrombopag tablets;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200062, China

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Thrombocytopenia

Interventions

hetrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Lu Wang, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang, Professor

CONTACT

18121299555; wang.lu99@hotmail.com

Ti Zhang, Professor

CONTACT

15800680751; zhangti@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 5, 2022
• Study Start: July 25, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)