Health Condition 1: D696- Thrombocytopenia, unspecified Health Condition 2: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Avatrombopag 20 mg tablet: Treatment Arm 01 - 30 patients will receive 40 mg Avatrombopag (2 tablets of 20 mg) once daily for 5 days if Platelet count is 40 to less than 50 10/L.
3
Sponsors
BDR Pharmaceuticals International Pvt. Ltd.
Raptim Research Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women greater than or equal to 18 years of age. 2. Patients diagnosed with chronic liver disease. 3. Model of End Stage Liver Disease (MELD) score of 24 or less at time of screening. 4. Patients who, are required to undergo an elective invasive procedure and who require a platelet transfusion to manage the risk of bleeding associated with the procedure. 5. A baseline platelet count less than 50,000 per Microliter. Platelet counts must be measure on two separate occasions, during screening and baseline and must be performed at least one day apart (The mean of these two platelet counts will be used for entry criteria and for assignment to either low or high platelet cohort). 6. Participants must be able and willing to provide written informed consent before undergoing any study-specific procedures. 7. Female participants of childbearing potential must have a negative serum or urine pregnancy test at screening and must agree to use highly effective contraceptive methods during the study period and for an appropriate duration after the last dose of the investigational product, as per protocol guidelines. 8. Patients agree to refrain from Kiwi, dragon fruit and papaya leaf extract, bleeding stopping injection during the study duration.
Exclusion criteria
Exclusion criteria: 1. Evidence of portal vein thrombosis on abdominal imaging (ultrasound with Doppler or appropriate MRI or CT imaging techniques) at screening. 2. History of arterial or venous thrombosis. 3. Portal blood velocity less than 10 cm per sec at screening. 4. Hepatic encephalopathy that cannot be treated. 5. HIV patients. 6. Post liver transplant patients. 7. History of significant cardiovascular disease, including CHF (NYHA Class III/IV), arrhythmias (e.g., atrial fibrillation), QTc greater than 450 ms, angina, coronary stent, angioplasty, or CABG. 8. Participants with severe hepatic impairment (Child-Pugh Class r C) with score above 12, 9. Concurrent malignancy except HCC. 10. Platelet transfusion within 7 days of screening. 11. Use of erythropoietin agents 7 days of screening. 12. Use of Heparin, warfarin, Aspirin and anti-platelet drugs. 13. Use of Interferon within 14 days of screening. 14. Any clinically significant active bleeding. 15. Participants with creatinine clearance less than 30 mL per min (calculated using the Cockcroft-Gault equation) will be excluded. 16. Hb less than 8 and more than 18 for men and less than 8 and greater than 15 for women. 17. Known hypersensitivity to Avatrombopag or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Test product Avatrombopag (60 mg tablet in patients with platelet count less than 40,000 per microliter of blood and 40 mg Avatrombopag in patients with platelet count from 40 to less than 50,000 per microliter of blood) as compared to placebo in removing the need for platelet transfusions or any rescue procedures for bleeding after randomization and up to 7 days following an elective procedure in patients with Chronic Liver Disease who have thrombocytopenia.Timepoint: 35 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the superiority of Test product Avatrombopag over Placebo to achieve a platelet count of greater than or equal to 50,000 per microliter of blood on the procedure day in patients with Chronic Liver Disease who have thrombocytopenia. 2. To evaluate the superiority of Test product Avatrombopag over Placebo to elevate platelet counts from baseline on procedure day in patients with Chronic Liver Disease who have thrombocytopenia. 3. To evaluate the safety of Test product containing Avatrombopag Tablet as compared to Placebo product to treat Thrombocytopenic patient with Chronic Liver Disease Undergoing Elective Invasive Procedures.Timepoint: 35 Days | — |
Countries
India
Contacts
Public ContactMr Mustafa Pardiwala
BDR Pharmaceuticals International Pvt. Ltd.
Outcome results
None listed