Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Taihe Hospital, Hubei University of Medicine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Avatrombopag+Standard medical treatment |
|
| Control group | Other | Standard medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Avatrombopag: PLT:30~50×10^9/L patients, 40 mg/d; PLT:<30×10^9/L patients, 60 mg/d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (thrombotic events, bleeding events, etc.) incidence; | Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks | 24 weeks |
| Incidence of complications of liver cirrhosis (infection, etc.) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Ning, MD., PhD. | Contact | +8602783662391 | qning@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Ning, MD., PhD. | Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of infectious disease, Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D013921 | Thrombocytopenia |
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001791 | Blood Platelet Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
| D005978 | Glutathione |
| D017228 | Hepatocyte Growth Factor |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016207 | Cytokines |
Not provided
Not provided
| The First Hospital of Jilin University |
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard medical treatment | Drug | Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al. |
|
|
Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks
| 24 weeks |
| Patients without platelet transfusion or rescue due to bleeding | Patients without platelet transfusion or rescue due to bleeding refers to the patients rate without platelet transfusion or rescue due to bleeding between the two groups at 24 week | 24 weeks |
| Proportion of patients readmitted | Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group | 24 weeks |
| Changes in total bilirubin level | Changes in total bilirubin level refers to the changes of total bilirubin at 24 week compared to baseline between the Intervention group and Control group. | 24 weeks |
| Changes in alanine aminotransferase level | Changes in alanine aminotransferase level refers to the changes of alanine aminotransferase at 24 week compared to baseline between the Intervention group and Control group. | 24 weeks |
| Changes in albumin level | Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group. | 24 weeks |
| Changes in prothrombin time level | Changes in prothrombin time level refers to the changes of prothrombin time at 24 week compared to baseline between the Intervention group and Control group. | 24 weeks |
| Changes in international normalized ratio level | Changes in international normalized ratio level refers to the changes of international normalized ratio at 24 week compared to baseline between the Intervention group and Control group. | 24 weeks |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |