The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Herombopag to see how well it works for patients with low platelet counts (thrombocytopenia) due to chronic liver disease who need to have surgery. There are two parts to the study. In Part A, researchers are trying to find the best dose of Herombopag for these patients. In Part B, the study will compare the effects of Herombopag to a placebo (a dummy treatment) to determine how effective and safe it is.

To participate, you need to be an adult aged 18 or older with a specific liver function score (Child-Pugh Class A or B) and a low platelet count of less than 50×10^9/L. You should also be scheduled for an elective surgery, which means it’s planned and not an emergency. However, if you have a history of blood clots or certain other medical conditions, you may not be eligible. If you join the study, you can expect regular check-ups and monitoring while receiving either the medication or placebo during the trial. It’s a great opportunity to contribute to research that could help improve treatment options for others in similar situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
• • 2. Platelet count less than 50×10\^9/L on baseline;
• • 3. Elective invasive procedures or surgeries that are planned.
• Exclusion Criteria:
• • 1. Any history of arterial or venous thrombosis, including partial or complete thrombosis;
• • 2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
• • 3. Portal vein blood flow velocity rate \<10 centimeters/second at Screening;
• • 4. There are other diseases that may cause thrombocytopenia.