Pegylated Interferon to Treat Chronic Hepatitis D
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Chronic Delta Hepatitis With Pegylated Interferon|
- Histological Response at 3 Years [ Time Frame: 3 years ] [ Designated as safety issue: No ]Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.
- Histological Response at 5 Years [ Time Frame: 5 years ] [ Designated as safety issue: No ]Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.
|Study Start Date:||August 2001|
|Study Completion Date:||October 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Peginterferon Alpha-2a
Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
Drug: Peginterferon Alpha-2a
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023322
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Theo Heller, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|