Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

NCT ID: NCT04906083

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50~100×10^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.

Conditions

Liver Failure; Thrombocytopenia; Decompensated Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Avatrombopag+Standard medical treatment

Group Type: EXPERIMENTAL

Avatrombopag

Intervention Type: DRUG

Avatrombopag:

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

Standard medical treatment

Intervention Type: DRUG

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

Control group

Standard medical treatment

Group Type: OTHER

Standard medical treatment

Intervention Type: DRUG

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

Interventions

Avatrombopag

Avatrombopag:

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

Intervention Type: DRUG

Standard medical treatment

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

Intervention Type: DRUG

Other Intervention Names

transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.

Eligibility Criteria

Inclusion Criteria

1. Men and women greater than or equal to 18 years of age;

2. Baseline platelet count <50×10^9/L;

3. End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;

4. 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;

5. Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;

6. Subject meet the criteria according to the opinion of the researchers.

Exclusion Criteria

1. Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;

2. Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;

3. Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);

4. Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);

5. 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);

6. 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;

7. The subject has a hypersensitivity to Avatrombopag or any of its excipients;

8. Subjects with drug-induced thrombocytopenia;

9. Subjects whose Life expectation ≤6 months;

10. Subject with a current malignancy;

11. Subjects with HIV infection;

12. At screening, active infection was not effectively controlled by systemic antibiotic therapy;

13. The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study;

14. The Investigator believe that there are any other factors that are not suitable for inclusion or affect participation or completion of the study;

15. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Taihe Hospital, Hubei University of Medicine

UNKNOWN

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qin Ning

Director of Department of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qin Ning, MD., PhD.

Role: STUDY_CHAIR

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

Locations

Department of infectious disease, Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qin Ning, MD., PhD.

Role: CONTACT

qning@vip.sina.com

+8602783662391

Facility Contacts

Qin Ning

Role: primary

qning@vip.sina.com

+8602783662391

Other Identifiers

TJ20210517

Identifier Type: -

Identifier Source: org_study_id