Status:
TERMINATED
Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia
Lead Sponsor:
University of Southern California
Conditions:
Hepatitis C Infection
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 thrombocytop...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01153919
Start Date
June 30 2010
End Date
July 14 2018
Last Update
April 11 2017
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033