Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study) (HepC)

This is an interventional treatment trial for Hepatitis C Read More

Inclusion Criteria:

• Diagnosis of thalassemia
• Serum positive for hepatitis C virus RNA by polymerase chain reaction (PCR) test (using the Roche COBAS Amplicor hepatitis C virus test)
• Hepatitis B surface antigen (HBsAg) negative and HIV negative within the 12 months prior to study entry
• Liver biopsy showing histologic evidence of active hepatitis (i.e., at least grade 1 inflammation)
• Willing to use acceptable forms of contraception throughout the study

Exclusion Criteria:

• Baseline liver iron concentration greater than 40.00 mg/g dry weight (iron may be chelated and the individual re-screened). All people with liver iron levels greater than 20.00 mg/g dry weight will be permitted to enroll only if their ejection fraction is 55 or greater by echocardiography (ECHO).
• Currently participating in other interventional clinical studies
• Received interferon-alfa therapy within the 6 months prior to study entry
• Liver dysfunction, defined as international normalized ratio (INR) greater than 1.3, albumin less than or equal to 3.5g/dL, or serum bilirubin greater than 4.0 mg/dL that, in the opinion of the investigator, is not due to Gilbert's syndrome or thalassemia-related hemolysis
• Other causes of liver disease (e.g., hereditary hemochromatosis, presumed drug-associated liver disease, Wilson's disease, obesity [body mass index (BMI) greater than 30])
• Major psychiatric illness
• Neutrophil count less than or equal to 1500/mm3
• Platelet count less than or equal to 80,000/mm3
• Active alcohol abuse within the 12 months prior to study entry
• Use of illicit drugs (e.g., heroin, cocaine, angel dust) within the 2 years prior to study entry
• Alpha-fetoprotein level greater than 200 ng/mL or evidence of a liver mass lesion by either ultrasound, CT scan, or MRI scan that is suspicious for hepatocellular cancer
• Kidney insufficiency, as defined by a clinically significant abnormal serum creatinine test and confirmed by a creatinine clearance rate of less than 50 mL/min based on 24-hour urine collection. People with an elevated serum creatinine level must undergo a creatinine clearance test.
• Diabetes that, in the opinion of the investigator, is not controlled by diet, an oral hypoglycemic agent, and/or insulin
• Received an organ, limb, or bone marrow transplant
• Requires the use of certain long-term medications such as immunosuppressive medications (e.g., corticosteroids, methotrexate, azathioprine)
• Active systemic autoimmune disorder (e.g., rheumatoid arthritis, systemic lupus)
• Diagnosis or treatment of cancer within the 5 years prior to study entry, except for localized squamous or basal cell cancers treated by local excision

• Any of the following pre-existing conditions that, in the opinion of the investigator, would prevent treatment with interferon and/or ribavirin:

  1. unstable heart disease that is not controlled by medication
  2. serious cerebrovascular disease
  3. serious lung disease
• History of a seizure disorder that has not been well-controlled by anti-seizure medications within the 2 years prior to study entry
• Pregnant or breastfeeding
• Male partners of women who are pregnant
• Any other condition that, in the opinion of the investigator, would prevent study participation
• Known hypersensitivity to any study drug or their components
• Past history of multiple sclerosis, transverse myelitis, optic neuritis, papilledema, chorioretinitis, uveitis, or increased ocular pressure/glaucoma
• Currently taking hematopoietic growth factors
• Currently taking ribavirin