A Double-Blind, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Romiplostim, Administered Once Weekly to Thrombocytopenic Hepatitis C (HCV) Infected Subjects Who Are Not Candidates for Antiviral Treatment With Pegylated Interferon and Ribavirin Due to Persistent Thrombocytopenia
I. To assess the platelet count response to administration of weekly romiplostim patients
with HCV infection whose initial platelet count is < 70,000/L.
I. To assess the safety and tolerability of romiplostim the treatment of patients with HCV
infection and thrombocytopenia; including physical symptoms and findings, hematologic, serum
chemistries and liver function tests and adverse events.
II. To assess the ability of romiplostim to enable subjects to achieve a platelet count
sufficient to start antiviral therapy.
III. To assess the ability of romiplostim to maintain platelet counts greater than 50,000/L
while receiving antiviral therapy with pegylated interferon and ribavirin.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of
disease progression or unacceptable toxicity.
Arm II: Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to
achieve a platelet count of > 100,000/L cross over to arm I.
Patients achieving a platelet count of > 100,000/L at 8 weeks receive PEG-interferon alfa-2a
subcutaneously once weekly and oral ribavirin once daily. Treatment repeats every 7 days for
24-48 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 and 36 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Mean platelet count for actively treated and placebo treated subjects
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration
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