Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection

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)

Timeline

Start

2003-08

Primary completion

—

Completion

2005-05

Drugs

Indications