Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

NCT04906083 | Unknown Phase 4

• 1 other identifier: TJ20210517
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.

Conditions

Liver Failure; Thrombocytopenia; Decompensated Cirrhosis

Keywords

end-stage liver disease; thrombocytopenia; avatrombopag; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Platelet count response time

  Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.

  24 weeks

Secondary Outcomes (9)

• Adverse Event (thrombotic events, bleeding events, etc.) incidence;

  24 weeks

• Incidence of complications of liver cirrhosis (infection, etc.)

  24 weeks

• Patients without platelet transfusion or rescue due to bleeding

  24 weeks

• Proportion of patients readmitted

  24 weeks

• Changes in total bilirubin level

  24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Avatrombopag+Standard medical treatment

Drug: Avatrombopag; Drug: Standard medical treatment

Control group

OTHER

Standard medical treatment

Drug: Standard medical treatment

Interventions

Avatrombopag DRUG

Avatrombopag: PLT：30\~50×10\^9/L patients, 40 mg/d; PLT：\<30×10\^9/L patients, 60 mg/d.

Intervention group

Standard medical treatment DRUG

Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.

Also known as: transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

• Men and women greater than or equal to 18 years of age;
• Baseline platelet count \<50×10\^9/L;
• End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;
• Women of childbearing potential must agree to use a highly effective method of contraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combination contraception \[including vaginal rings\], intra-uterine devices or vasectomy). The barrier contraception with or without spermicide alone, double barrier contraception and oral contraceptives are inadequate;
• Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;
• Subject meet the criteria according to the opinion of the researchers.

You may not qualify if:

• Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;
• Known portal vein blood flow velocity rate \<10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;
• Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
• Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);
• Subject has a recent history (within the previous 6 months) of significant cardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmias known to increase the risk of thromboembolic events \[e.g. atrial fibrillation\], coronary or peripheral artery stent placement or angioplasty, and coronary or peripheral artery bypass grafting);
• Female subjects who are lactating or pregnant at the Baseline Visit (as documented by a positive serum beta-human chorionic gonadotropin \[β-hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to become pregnant during the study;
• The subject has a hypersensitivity to Avatrombopag or any of its excipients;
• Subjects with drug-induced thrombocytopenia;
• Subjects whose Life expectation ≤6 months;
• Subject with a current malignancy;
• Subjects with HIV infection;
• At screening, active infection was not effectively controlled by systemic antibiotic therapy;
• The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study;
• Subject is enrolled in another clinical study with any investigational drug or device within previous 30 days of the Baseline Visit, but are allowed to participate in observational studies.

Sponsors & Collaborators

• Tongji Hospital: lead
• Anhui Provincial Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Taihe Hospital, Hubei University of Medicine: collaborator
• The First Hospital of Jilin University: collaborator

Study Sites (1)

Department of infectious disease, Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Liver Failure; Thrombocytopenia; End Stage Liver Disease

Interventions

avatrombopag; Glutathione; Hepatocyte Growth Factor

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Qin Ning, MD., PhD.

  Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

  STUDY CHAIR

Central Study Contacts

Qin Ning, MD., PhD.

CONTACT

+8602783662391; qning@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Infectious Diseases

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 28, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

CN (1)