Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia.

This protocol will provide access to TheraSphere® treatment for patients who have refractory thrombocytopenia secondary to cirrhosis. This protocol will utilize splenic artery-directed TheraSphere® treatment.

Inclusion Criteria:

• Male or female, 18 years of age or older, of any ethnic or racial group.
• Diagnosis of cirrhosis or portal hypertension with a serum platelet count less than or equal to 80 × 109/L. [Rationale: platelet count <100 × 109/L triples the rate of liver-related adverse events (3) and worsens postoperative survival in the setting of hepatocellular carcinoma (HCC) (4). Initial platelet count of 80 × 109/L can allow the majority of patients who successfully respond to 90Y-RE (clinical endpoint of 50% platelet count increase) to exceed the 100 × 109/L threshold.]

Cirrhosis is defined by one of three criteria:

• Liver Biopsy/histology consistent with cirrhotic architectural liver changes
• Portal hypertension (Hepatic venous pressure gradient ≥10 mm Hg)
• Evidence of esophageal and/or gastric varices
• Patients must have evidence of splenomegaly as determined by screening cross-sectional imaging.
• No evidence of myelosuppression (e.g. lymphopenia) as evidenced by normal hematology values at Screening
• Adequate baseline organ function(with the exception of cirrhosis) as evidenced by normal BUN/Cr and electrolytes on screening chemistry.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
• Patient has a life expectancy of greater than 6 months without intervention.
• Patient is willing to participate in the study and has signed the study informed consent.
• Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to screening and must not be breastfeeding.

Exclusion Criteria:

• Patients with serum platelet count less than 10 × 109/L.
• History of bleeding disorder attributed to another cause other than cirrhosis (e.g. Von Willebrand disease)
• Declines or unable to provide informed consent
• History of prior partial splenic embolization (PSE) or splenectomy
• Use of any medication known to increase platelet count 1 month prior to Baseline.
• History of allergy or sensitivity to TheraSphere® or its components.
• History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
• Contraindications to angiography and selective visceral catheterization such as bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device)
• Previous randomization in a trial using 90Y RE
• Patient must not have participated or enrolled in a clinical trial with an investigational device / therapy within 30 days prior to randomization
• Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, and uncontrolled congestive heart failure or respiratory disease.
• Patients actively on chemotherapy.