Pegylated Interferon to Treat Chronic Hepatitis D
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ClinicalTrials.gov Identifier: NCT00023322 |
Recruitment Status
:
Completed
First Posted
: September 3, 2001
Results First Posted
: July 10, 2013
Last Update Posted
: July 10, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis D | Drug: Peginterferon Alpha-2a | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Chronic Delta Hepatitis With Pegylated Interferon |
Study Start Date : | August 2001 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
---|---|
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.
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Drug: Peginterferon Alpha-2a
Treatment
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- Histological Response at 3 Years [ Time Frame: 3 years ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) |
Additional Information:
Publications:
Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00023322 History of Changes |
Other Study ID Numbers: |
010247 01-DK-0247 ( Other Identifier: National Institutes of Health ) |
First Posted: | September 3, 2001 Key Record Dates |
Results First Posted: | July 10, 2013 |
Last Update Posted: | July 10, 2013 |
Last Verified: | July 2013 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Cirrhosis Chronic Hepatitis Alpha Interferon Hepatitis D Virus Delta Hepatitis Viral Hepatitis |
Antiviral Agents Hepatitis D HDV Liver Hepatitis |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis D Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Interferons Peginterferon alfa-2a Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |