This study will test whether gamma interferon is effective in treating chronic hepatitis C
infection-a long-lasting viral infection affecting the liver. One-third of patients with
hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or
liver cancer. The current treatment for hepatitis C infection is pegylated alpha interferon
(peginterferon) plus ribavirin; however, this treatment is successful in only about half of
patients. Gamma interferon works similarly to alpha interferon, but through different
pathways, and therefore might be helpful in patients who do not respond to alpha interferon.
Patients 18 years of age and older with chronic hepatitis C infection, genotype 1, who did
not respond to alpha interferon and ribavirin therapy may be eligible for this study.
(Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate.)
Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a
medical evaluation to determine eligibility for the study and, if enrolled, to begin gamma
interferon therapy. Screening will include a medical history and physical examination, blood
and urine tests, and possibly chest X-ray, abdominal ultrasound, and psychiatric evaluation.
Participants will receive injections of gamma interferon under the skin 3 times a week for 4
weeks (a total of 12 injections). They will be randomly assigned to receive either 100 or 200
micrograms of drug per injection. Blood will be drawn just before the first injection and
then 6, 12, 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and
immune responses to treatment. The amount and rapidity of decrease in virus will be compared
with what occurs with alpha interferon treatment to define the relative effectiveness of
gamma interferon. (Patients may leave the hospital at any time after the first day, but must
return in time for the final blood test.)
Patients will be seen in the clinic each week during treatment to report symptoms and drug
side effects and to have blood drawn for routine tests and viral levels. After the 4-week
treatment is completed, patients will return for follow-up visits at weeks 6 and 8 for
routine blood tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)