Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)
Condition: Hepatitis C; Thalassemia
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Thalassemia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Hepatitis C is an inflammation of the liver that is caused by infection with the hepatitis C
      virus. Over time, people may develop liver failure, liver cancer, or cirrhosis, a condition
      in which the liver may become permanently scarred. Ribavirin and peginterferon alfa-2a are
      two medications that are used to treat hepatitis C. Ribavirin stops the hepatitis C virus
      from spreading inside the body, and peginterferon alfa-2a decreases the amount of hepatitis C
      virus in the body. Individuals with thalassemia, an inherited blood disorder that can cause
      anemia, often receive regular blood transfusions as part of their treatment. These
      individuals may have an increased risk of developing hepatitis C as a result of blood
      transfusions received before routine hepatitis C blood screening was available. Treating
      thalassemia patients with standard hepatitis C therapy can be difficult because ribavirin can
      worsen anemia. However, omitting ribavirin then increases the risk of hepatitis C relapse
      following treatment. The purpose of this study is to evaluate the safety of ribavirin and
      peginterferon alfa-2a for treating hepatitis C in adults with thalassemia.

      This study will enroll adults with thalassemia and long-term hepatitis C. Participants will
      attend study visits weekly for 4 weeks, every 2 weeks until Week 24, every 4 weeks until Week
      48, and then every 6 weeks until Week 72. All participants will receive a peginterferon
      alfa-2a injection once a week and ribavirin daily. Participants with the hepatitis C genotype
      1 will receive 48 weeks of treatment; participants with all other genotypes of the disease
      will receive 24 weeks of treatment. A liver biopsy will occur at baseline and Week 48. The
      following will occur at selected study visits: physical exam, blood and urine collection,
      hearing and vision screening, chest x-ray, heart rate monitoring, and questionnaires to
      assess hepatitis C symptoms, quality of life, and depression. Participants with liver iron
      levels greater than 20 mg/g will undergo an echocardiogram ultrasound test every 3 months to
      monitor the heart.
    

Intervention name(s): Peginterferon Alfa-2a and Ribavirin; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be treated with alfa-2a and ribavirin as follows:
Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly.; Ribavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight > 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
Other intervention name(s): Human recombinant E. Coli; Hoffmann-la Roche
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment