Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

• Status: Terminated
• Trial end date: 2018-07-14
• Target enrollment: 0
• Participant gender: All

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 thrombocytopenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

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