Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
Summary
Phase I/II trial of KRN7000 in patients with chronic hepatitis C.
Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of
a-GalCer.
The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy
parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of
a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.
Number of dose levels: 3 Investigational product: KRN7000 Route of administration:
intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day
28 and day 56)