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Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Sponsored by USC/Norris Comprehensive Cancer Center

Phase Quota
Phase 2

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 Start Date: March 2010

Estimated Completion Date: April 2016

Specialties: Internal Medicine: Infectious Disease Nursing: Immuno/Infectious Dz Infectious Disease: Hepatitis Gastroenterology: Hepatology Physician Assistant: Infectious Disease

Interventions

  • Drug: ribavirin
  • Other: laboratory biomarker analysis
  • Biological: PEG-interferon alfa-2a
  • Biological: romiplostim
  • Other: placebo

Inclusion criteria

  • 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 criteria

  • 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

Study Locations And Contact Information

  • USC/Norris Comprehensive Cancer Center, Los Angeles California
    Contact: Teh-Chun Wang, RN 323-865-3978 Teh-Chun.Wang@med.usc.edu

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