At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Elevated transaminases (ALT >41 or AST >31 U/L) on average of 3 determinations over 6 months
- ✓Anti-HDV antibody present in serum
- ✓Chronic hepatitis on liver biopsy within 12 months with necroinflammatory score ≥5 (out of 18) and fibrosis score ≥1 (out of 6)
- ✕Decompensated liver disease: bilirubin >4 mg%, albumin <3.0 gm%, PT >2 seconds prolonged, or history of esophageal varices, ascites, or hepatic encephalopathy
- ✕ALT >1000 U/L (>25× ULN) until normalized on repeat testing
- ✕Pregnancy or inability to use adequate contraception in women of childbearing potential or spouses
- ✕Significant systemic/major illness: congestive heart failure, renal failure (CrCl <50 ml/min), organ transplant, serious psychiatric disease/depression, angina pectoris
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Chronic Delta Hepatitis With Pegylated Interferon
In Brief
A Phase 2 clinical trial evaluating Peginterferon Alpha-2a for Hepatitis D. Completed, enrolled 13 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
Treatment