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Treatment of Chronic Delta Hepatitis with Pegylated Interferon
This study is NOT currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
01-dk-0247 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: No longer recruiting/follow-up only |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Cirrhosis; |
Recruitment Keyword(s) |
Viral Hepatitis; |
Condition(s) |
Hepatitis D |
Investigational Drug(s) |
Peginterferon Alpha-2a |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Peginterferon Alpha-2a |
Supporting Site |
|
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.
Eligibility
INCLUSION CRITERIA:
Age greater than or equal to 18 years, male or female
Serum alanine or aspartate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 U/L) on an average of three determinations taken during the previous 6 months. The mean of the three determinations will be defined as 'baseline' levels.
Presence of anti-HDV in serum.
Evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
Presence of HDV antigen in liver tissue.
Written informed consent.
Previous standard alpha interferon or other antiviral activity will not exclude patients.
Active HBV replication will not exclude patients.
All ethnicities.
Patients will need to meet the first six entry criteria to enroll.
EXCLUSION CRITERIA:
Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
Pregnancy or, in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device, or Depo-Provera, or Norplant.
Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), and angina pectoris.
Immunosuppressive therapy within the last 6 months.
Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, and alpha-1-antitrypsin deficiency).
Any evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Theo Heller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9C432B MSC 1800 10 CENTER DR BETHESDA MD 20892-1800 (301) 402-7147 theoh@intra.niddk.nih.gov |
Theo Heller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9C432B MSC 1800 10 CENTER DR BETHESDA MD 20892-1800 (301) 402-7147 theoh@intra.niddk.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00023322
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