This study will evaluate the safety and effectiveness of a long-acting form of alpha
interferon called pegylated interferon in treating hepatitis D virus (HDV) infection. HDV
only infects people who already have hepatitis B infection. HDV is often severe and
progressive. Alpha interferon is the standard treatment for HDV, given by injection once a
day or three times a week for up to 12 months. However, this treatment does not work for
everyone, and those who respond usually relapse when the drug is stopped. The
sustained-release form of the drug, pegylated interferon, is given just once a week.
Pegylated interferon is more effective than standard interferon in hepatitis C patients, with
patients experiencing longer-term improvement. This study will evaluate the effects of
pegylated interferon on hepatitis D and hepatitis B. It will determine whether long-term
therapy with this drug improves inflammation and scarring of the liver, thereby delaying or
reversing cirrhosis, and whether the improvement can be maintained.
Patients with chronic hepatitis D over 6 years old may be eligible for this study.
Participants will have a medical evaluation, including a history and physical examination,
blood tests, routine urinalysis and 24-hour urine collection. Chest X-ray, electrocardiogram,
abdominal ultrasound and liver biopsy will be done if these tests have not been done within
the last year. In addition, depending on their age and individual health status, some
patients may have exercise stress testing, an eye examination, hearing test, and psychiatric
consultation. All patients will fill out a health-related quality of life questionnaire.
Patients will receive pegylated interferon by injection once a week and have blood tests to
measure the effects of treatment on the liver and on HBV and HDV levels. The medical
examination and liver biopsy will be repeated at the end of 12 months. Patients who improved
with treatment may continue therapy long-term. Medical evaluations and liver biopsies will be
repeated at 3 years and at 5 years.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)