Chronic liver disease-acquired hypofibrinogenemia
Conditions
Interventions
Experimental group:Intravenous infusion of human fibrinogen (Grand Shuyang Life Sciences (Chengdu) Co., Ltd.)
Control group:Intravenous infusion of human fibrinogen (Jiangxi Boya Bio-Pharmaceutical Co., Ltd)
Sponsors
Southern Medical University, Nanfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, male or female; 2. Patients with clinically confirmed chronic liver disease acquired hypofibrinogenemia, defined as meeting both of the following 2 criteria: a) Clinically diagnosed chronic liver disease, including viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, etc.; b) Patients with acute bleeding and functional fibrinogen level <=150 mg/dL; or patients who are scheduled for elective surgery (including traumatic or invasive procedures such as deep venipuncture, liver puncture, abdominal puncture, etc.) with a functional fibrinogen level of <=120 mg/dL 3. All subjects of childbearing potential must use effective contraception after entering the screening period until 3 months after the completion of the study; 4. Subjects give voluntary informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be eligible to participate in this clinical trial: 1. Patients with a history of allergy and intolerance to human fibrinogen, its excipients, or other human plasma proteins; 2. Patients with a Child-Pugh score >13 (Appendix 1); 3. Patients with Grade 2 or higher hepatic encephalopathy (HE) (Appendix 2); 4. Patients with clinically assessed uncontrollable active infections, disseminated intravascular coagulation (DIC), or primary hyperfibrinolysis. 5. Patients with severe life-threatening bleeding, such as intracranial hemorrhage or massive gastrointestinal bleeding (e.g., gastrointestinal bleeding caused by portal hypertension or esophageal and gastric variceal bleeding); 6. Patients diagnosed with congenital hypofibrinogenemia/afibrinogenemia; 7. Patients with severe or extremely severe anemia (hemoglobin <60 g/L) requiring blood transfusion; 8. Patients with other severe hematological diseases, such as leukemia, lymphoma, and aplastic anemia, deemed unsuitable for participation by the investigator; 9. Patients with severe cerebrovascular events (e.g., intracerebral hemorrhage, cerebral thrombosis, cerebral infarction) or severe deep vein thrombosis, pulmonary embolism, or arterial embolism within the past year, deemed unsuitable for participation by the investigator; 10. Patients with severe cardiovascular complications, including unstable angina, malignant arrhythmia, acute myocardial infarction, or heart failure (defined as NYHA Grade III and IV, see Appendix 3); 11. Patients with malignant tumors who have an expected survival of less than 3 months or an ECOG score =2 (see Appendix 4); 12. Patients with mental illness and significant psychiatric disorders, active epilepsy; those lacking cognitive or behavioral ability; substance abusers or addicts; or those unable to abstain from heavy drinking during the trial period; 13. Patients with laboratory test results during the screening period showing: a) Platelet count <30×10^9/L. b) Positive HIV antibody (or nucleic acid test) or syphilis antibody. 14. Patients who have received human fibrinogen, human prothrombin complex, or human coagulation factors VIIa/VIII/IX treatment within 1 week before the first dose. 15. Patients who have used anticoagulants or antiplatelet drugs (e.g., warfarin, heparin, aspirin, etc.) within 1 week before the first dose. 16. Pregnant or lactating women, or those intending to conceive or breastfeed during the trial period. 17. Subjects who have participated in other drug clinical trials and used trial medications within 1 month before signing the informed consent form. 18. Subjects deemed unsuitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Active Recovery Rate;Hemostasis success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with fibrinogen levels reaching 200 mg/dL and the distribution of subjects at different fibrinogen levels.;Changes in coagulation parameters of subjects after infusion of the investigational drug;Comparison of the dosing and infusion frequency for bleeding treatment in subjects;Comparison of the clinical efficacy of perioperative bleeding management in subjects; | — |
Countries
China
Contacts
Public ContactJinjun Chen
Southern Medical University, Nanfang Hospital
Outcome results
None listed