Protocol Number: 03-DK-0136

Title:

Low Dose Peginterferon and Ribavirin Therapy for Patients with Chronic Hepatitis C Infected with Genotype 2 or 3

Number:

03-DK-0136

Summary:

This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure. This disease is caused by the hepatitis C virus (HCV). There are six major strains, or genotypes, of HCV. Patients infected with genotypes 2 and 3 respond better and more quickly to the standard treatment for this disease-high-dose peginterferon and ribavirin for 24 to 48 weeks-than do patients with other genotypes. Although the side effects of these medications are more severe at higher doses, patients with all genotypes, including genotypes 2 and 3, currently receive the same standard treatment. This study will examine whether patients infected with HCV genotypes 2 and 3 will respond equally well, and with fewer side effects, to lower doses of peginterferon and ribavirin given for a shorter period of time.

Patients 18 years of age and older with chronic hepatitis C genotype 2 or 3 may be eligible for this study. Each candidate will be screened with a medical history, physical examination, blood tests, and liver ultrasound. Patients who have not had a chest x-ray or electrocardiogram within a year of entering the study will have those tests as well. Additional tests, such as eye examination, hearing test, stress test, or others, will be done if deemed necessary because of the individual's particular medical condition or risk factors for side effects of therapy.

Participants will be admitted to the NIH Clinical Center for 1 day for supervised administration of the first doses of peginterferon and ribavirin and 24-hour observation. The treatment regimen consists of two capsules of ribavirin twice a day every day and an injection of peginterferon under the skin once a week. Patients will return to the clinic at 2, 4, 8, 12, 16, 20 and 24 weeks after the first dose of therapy for a brief medical history and physical examination, blood test, and check on hepatitis symptoms and treatment side effects. Women capable of becoming pregnant will also have a pregnancy test at each visit.

Patients will be tested for HCV levels after 12 weeks of therapy. Those who are negative for the virus at that time will continue therapy for another 12 weeks to insure that the response lasts. They will be monitored during that time and re-tested for the virus at the end of that period. Patients who do not respond to treatment after 12 weeks will stop low-dose therapy and be offered the higher-dose standard treatment for 48 weeks. Patients who responded after 12 weeks and completed 24 weeks of therapy but subsequently became positive after stopping treatment will also be offered standard high-dose treatment for the full 48-week regimen. Patients on high-dose therapy will return to the clinic every 4 weeks during the 48-week course for evaluation and blood tests. Patients who remain positive for HCV after 24 weeks of high-dose therapy will stop treatment, as a response is unlikely to occur beyond that time.

After treatment, patients will return to the clinic at 4- to 8-week intervals for evaluations until 6 months. At 6 months, they will have a series of blood and urine tests and ultrasound of the liver.

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):

Hepatitis C Virus

Antiviral Agents

Hemolysis

Neutropenia

Cirrhosis

Hemolytic Anemia

Viral Hepatitis

Ribavirin

Alfa Interferon

Pegylated Interferon

Recruitment Keyword(s):

Hepatitis C

HCV

Condition(s):

Hepatitis C

Investigational Drug(s):

Peginterferon alfa-2a and ribavirin

Investigational Device(s):

None

Interventions:

Drug: Peginterferon alfa-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. Review.

Major ME, Feinstone SM. The molecular virology of hepatitis C. Hepatology. 1997 Jun;25(6):1527-38. Review.

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009