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Protocol Number:
02-DK-0065
- Title:
Combination of Pegylated Interferon and Ribavirin as Therapy for Patients with Chronic Hepatitis C with and without Renal Disease
- Number:
02-DK-0065
- Summary:
This study will examine the effectiveness of pegylated interferon, or peginterferon (a long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1) infection with and without kidney disease. (Genotype 1 is a strain of hepatitis C virus that has a lower success rate of therapy.) Combination therapy with alpha interferon and ribavirin is the recommended treatment for hepatitis C infection in patients without kidney disease. However, it is not successful in all patients. An early predictor of who is or is not likely to respond to therapy would allow treatment to be stopped in non-responders within 2 to 4 weeks rather than 6 or 12 months. This study will determine whether early changes in viral levels with treatment predict the ultimate outcome. It will also compare responses in patients without and with kidney disease to better evaluate problems of therapy in the latter group. Ribavirin is not given to people with kidney disease because of possible severe drug side effects. However, because patients with kidney disease are poor treatment responders and because ribavirin increases the success of therapy in patients without kidney disease 2- to 3-fold, however, this study will look for a dose of the drug that can safely be given to patients with kidney disease.
Patients 18 years of age and older with hepatitis C, genotype 1, with or without kidney disease may be eligible for this study. Candidates will be screened with a medical history and physical evaluation, blood tests, symptom questionnaires, 24-hour urine collection, chest X-ray, electrocardiogram, and liver ultrasound. A liver biopsy (removal of a small piece of liver tissue) will be done in patients who have not had one within the last year. Additional procedures, such as eye examination, treadmill stress test, hearing test, or others may be required depending on the individual's medical condition.
Patients without kidney disease will be randomly assigned to one of two treatment groups: Group A will take both peginterferon (by injection under the skin once a week) and ribavirin (capsules by mouth) from the start of therapy; Group B will start treatment with peginterferon alone and add ribavirin after 4 weeks. Patients with kidney disease (Group C) will start with peginterferon alone and add ribavirin 4 weeks later. All patients will be admitted to the NIH Clinical Center for a few days when treatment starts in order to draw blood at precise intervals (6, 12, 24, 48, and 72 hours after the first peginterferon injection) for measurements of viral levels.
Blood will then be drawn once a week for 4 weeks (just before each injection) to determine how rapidly viral levels decrease with treatment and to measure blood levels of interferon and ribavirin. After 4 weeks of therapy, patients will have a blood test and check of symptoms and side effects every 4 weeks for 24 weeks (every 2 weeks for Group C patients until the optimum ribavirin dose is found) and then every 8 weeks for the remainder of the study. They will have a physical examination and urine test every 12 weeks.
Patients will be tested for hepatitis virus RNA after 24 weeks of therapy to determine if they are a responder or non-responder. Responders will be advised to continue therapy for a full 48 weeks to ensure a continued response when treatment stops. Non-responders-whose chances for a lasting response are estimated at only 2%-will be offered the option to continue treatment, to stop treatment and continue being followed without treatment, or to enroll in other studies of non-responders.
At the end of the 72-week treatment and follow-up, patients will have the same blood and urine tests as were done at the beginning of the study and a repeat liver ultrasound.
- Sponsoring Institute:
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Chronic Hepatitis
-
Cirrhosis
-
Hepatitis C Virus
-
Hemolysis
-
Ribavirin
-
Alpha Interferon
-
Peginterferon
-
Antiviral Agents
-
Viral Hepatitis
-
Hemolytic Anemia
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Renal Failure
-
Renal Dialysis
- Recruitment Keyword(s):
-
Hepatitis
-
Hepatitis C
- Condition(s):
-
Chronic Hepatitis C
- Investigational Drug(s):
-
Pegylated Interferon Alpha-2a and Ribavirin
- Investigational Device(s):
- None
- Interventions:
-
Drug: Pegylated Interferon Alpha-2a and Ribavirin
- Supporting Site:
-
National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, Natural History, Treatment, and Prevention of Hepatitis C. Ann Intern Med. 2000 Feb 15;132(4):296-305.
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Major ME, Feinstone SM. The Molecular Virology of Hepatitis C. Hepatology. 1997 Jun;25(6):1527-38.
-
Kiyosawa K, Sodeyama T, Tanaka E, Gibo Y, Yoshizawa K, Nakano Y, Furuta S, Akahane Y, Nishioka K, Purcell RH, et al. Interrelationship of Blood Transfusion, Non-A, Non-B Hepatitis and Hepatocellular Carcinoma: Analysis by Detection of Antibody to Hepatitis C Virus. Hepatology. 1990 Oct;12(4 Pt 1):671-5.
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