RATIONALE: Romiplostim may cause the body to make platelets. PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.
PRIMARY OBJECTIVES: I. To assess the platelet count response to administration of weekly romiplostim patients with HCV infection whose initial platelet count is \< 70,000/L. SECONDARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mean platelet count for actively treated and placebo treated subjects
Time frame: Weeks 6-8
Incidence of adverse events, including clinically significant changes in laboratory values and the incidence of antibody formation
Time frame: Weeks 1-24
Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L
Time frame: Week 8
Number of patients originally receiving active treatment who maintain a platelet count > 50,000/L while receiving anti-viral therapy with pegylated interferon and ribavirin
Time frame: Weeks 9-24
Changes in plasma HCV viral load during treatment with romiplostim alone
Time frame: Weeks 1-8
Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim
Time frame: Weeks 9-24
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Given subcutaneously
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