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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatitis C is one of the most common causes of long-term liver disease in the United States. Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C infection. The purpose of this study is to evaluate the safety of these two medications in adults with hepatitis C and thalassemia, a type of blood disorder.

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

Details

• Lead Sponsor: HealthCore-NERI; New England Research Institutes
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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