Expired Study
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Los Angeles, California 90033


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion - All patients with HCV virus infection documented by detectable plasma HCV antibodies and RNA who would be excluded by FDA criteria for antiviral treatment with peginterferon-alpha 2a and ribavirin due to thrombocytopenia (platelets < 70,000/L); patients cannot have received previous anti-viral therapy with interferon/ribavirin - Liver biopsy indicating chronic hepatitis within the previous 2 years - Mean platelet count of < 70,000/L on two repeated measurements in a two week screening period with no single count >= 75,000/L - Neutrophil count of >= 1000/mcl - Hemoglobin >= 11gm/dL and no evidence of active bleeding - Prothrombin Time (PT) INR < 1.6 seconds - Albumin >= 2.5 gm/dL - ALT >= 1.2 and < 10 times upper limit of normal - No evidence of either ischemic change or cardiac injury on 12-lead electrocardiogram (EKG) - Negative pregnancy test and women must be using adequate contraception for at least 2 weeks prior to enrollment and while enrolled in the study - Signed informed consent within 2 weeks of enrollment and randomization Exclusion - Received previous anti-viral therapy with interferon/ribavirin - Child's Class B and C or acute decompensated liver disease - Human Immunodeficiency Virus (HIV) infection or co-infected with hepatitis B virus - Any untreated active infection - Active malignancy, known primary bone marrow disorder (myelodysplasia, myeloproliferative disease, etc.), or history of blood or bone marrow transplantation; patients with documented hemoglobinopathies - Active vasculitis associated with cryoglobulinemia as manifested by either renal disease or dermatologic findings - Positive pregnancy test or men with pregnant partners - Creatinine and BUN of greater than twice (2x) the upper limits of normal - History of venous or arterial thrombosis, myocardial infarction or thrombotic stroke - Patients who in the investigators opinion will fail to be compliant or have other contraindication to treatment on this study - Other inherited or acquired liver disease - Previous solid organ transplant - Known hypersensitivity to E. coli derived recombinant proteins - Active rheumatologic disease including Systemic Lupus Erythematosis - Known history of Disseminated Intravascular Coagulation, Hemolytic Uremic Syndrome, or Thrombotic Thrombocytopenic Purpura


NCT ID:

NCT01153919


Primary Contact:

Principal Investigator
Howard Liebman
University of Southern California


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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